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HeartWare Files FDA Application For Heart-Pump Device December 29, 2010
HeartWare International Inc. (HTWR) filed a premarket approval application with the U.S. Food and Drug Administration for its heart-pump device for use in patients awaiting heart transplant.
The medical-device company's stock has more than doubled this year, with the most recent rally due to last month's announcement that the heart pump was able to keep more than 90% of patients alive six months after having received it.
The study met a goal showing the device worked as well as other heart-pumping devices. HeartWare's Ventricular Assist System poses a big threat to the current dominant position of Thoratec Corp's (THOR) HeartMate II mainly because of its smaller size, which means it requires less invasive surgery.
The products, known as ventricular assist devices, help a damaged heart pump blood. Shares were inactive premarket
Man uses portable driver to power artificial heart December 19, 2010
One week ago, William "Bill" Haley became just the third person in the nation to leave a hospital using a portable driver to power his Total Artificial Heart. Haley, who has moved from Kansas, Okla., to Lawton to await a heart transplant, is part of a clinical study by SynCardia, which makes the Total Artificial Heart and the portable Freedom Driver that allows him to escape the confines of the hospital.
As a part of the trial, 30 patients must be discharged from a hospital using the portable device. After being discharged, patients are then followed until transplant, death or 90 days of Freedom driver support.
Unlike traditional heart pumps that assist one side of the heart or the other left or right ventricular assist devices the Total Artificial Heart actually replaces both ventricles of the failing heart. It is the only FDA-approved device of its kind, according to Holly Wright, a nurse at INTEGRIS Baptist Medical Center in Oklahoma City.
In order to utilize the artificial heart, the natural heart is physically removed. Garrett Morgan, a circulatory system educator with INTEGRIS, said the device is not meant to be a permanent solution "It allows the patient to recover (from heart failure)," Morgan said. "This (device) is meant to increase function and bridge to the transplant process."....read more
FDA Approves Use of Temporary Pump to Assist Heart’s Right Side December 13, 2010
The U.S. Food and Drug Administration(FDA) today approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of the heart. The approval is a first for certain critically ill patients.
Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart’s left ventricle, which pumps oxygen-rich blood to the rest of the body. The pump, manufactured by Levitronix LLC, is called the CentriMag Right Ventricular Assist System, is intended for patients requiring support for the heart’s right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen.
HDEs facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the United States every year. To receive approval of an HDE application, a company must demonstrate the product’s safety and probable benefit. Such products are generally used under the supervision of an Institutional Review Board, a committee that approves, monitors, and reviews biomedical research within a locality.
The CentriMag system is for critically ill patients with a failing right ventricle when other therapies have failed. It is intended to be used for up to 14 days to keep the patients alive until their heart recovers or until a heart transplant or long-term heart assist device can be implanted.
Safety data from two multi-center clinical trials showed that the CentriMag system does not expose patients to an unreasonable risk, and the probable health benefit from use of the device outweighs the risk, taking into account the probable risks and benefits of alternative forms of treatment....continue reading
FDA grants study of Abiomed heart device December 6, 2010
Cardiac medical device maker Abiomed Inc. has won conditional approval from the U.S. Food and Drug Administration for a pilot study to test its Impella 2.5 device reducing heart muscle damage in patients with ST-elevation myocardial infarction (STEMI).
The study, called MINI-AMI, will look at whether using the Impella 2.5 heart pump for 24 hours after percutaneous intervention helps to reduce the blockage of blood flow, as compared to standard procedures post-percutaneous intervention.
The study follows a theory the company holds that its heart pump will be able to reduce the overall infarct area, the area with the obstructed blood supply, due to the device’s “ability to directly unload the left ventricle,” according to a news release from Abiomed.
Artificial Heart Rejects High Tech? Lessens Learnt from Non-pulsatile VAD with Straight Impeller Vanes Posted: December 6, 2010
Abstract: Despite the progresses in developing pulsatile impeller pump and impeller total heart, as well as in applying streamlined impeller vanes, the best results in application of artificial heart pumps have been achieved by nonpulsatile univentricular assist pump with straight impeller vanes until now. It seems all efforts and successes have been done in vain because artificial heart rejects Hi-Tech!
This paper recalls some important achievements in R&D of artificial heart in past 25 years and shares author’s experiences with the readers.
• View or download .pdf file
Abiomed Ends Study Using Impella Heart Pump, Shares Fall December 6, 2010
(RTTNews) - Shares of medical devices maker Abiomed Inc. (ABMD) dropped more than 13% in after-hours trading on Monday after the company said it has ended a study of its heart pump Impella as it was unlikely to achieve the primary objectives of the study.
Danvers, Massachusetts-based Abiomed said the Protect II study was stopped "due to unanticipated confounding variables related to the use of rotational atherectomy" in the study. The company added that the decision to end the study followed the recommendation of the Data Safety Monitoring Board or DSMB.
The study was designed to measure major adverse events at 30 days in high risk percutaneous coronary intervention or PCI patients randomized to receive hemodynamic support during the procedure with Impella, compared to an intra-aortic balloon or IAB.
Abiomed said it faced "confounding" results in a population of patients with atherectomy, which comprised 12% of the interim study population. The company noted that 72% of the patients in the Impella arm experienced major adverse events, compared with 46% on the intra-aortic balloon.
William O'Neill, Principal Investigator of the PROTECT II study, said, "Atherectomy was an unanticipated variable which resulted from the operators' decision to 'do more with Impella.' Our investigators had unblinded knowledge of the treatment arm after randomization. It is interesting that operators felt that they could do more complex interventions once randomized to Impella and this in and of itself is an important finding."
Announcing interim results, Abiomed noted that for the entire study population....continue reading
Heart pump simulator built by oil engineers help doctors study blood flow Posted" December 11, 2010
The worlds of energy and medicine came together this week at the annual Pumps and Pipes event at The Methodist Hospital in Houston. Engineers from ExxonMobil demonstrated a heart simulator that will enable doctors in the Methodist DeBakey Heart & Vascular Center to study blood flow and heart valve disease more precisely than ever before. The device has no metal parts so flow can be studied in detail using MRI (magnetic resonance imaging).
Can the Artificial Heart Replace the Real Thing? November 30, 2010
Human Heart “real thing”: The heart begins to beat 4 weeks after conception & doesn’t stop until death. An adult heart can pump up to 2,000 gallons of blood each day which is roughly 5 quarts of blood a minute. It is capable of beating over 100,000 times a day. It will beat over 2.5 billion times in the average life span of 70 years. The heart consists of 4 chambers a right & left atrium as well as a right & left ventricles Both the right and left atrium hold about 3.5 tablespoons of blood where the right ventricle can hold about a quarter cup of blood. The left atrium is about three times thicker than the right.
Heart Function: 1: When the heart is at rest the right atria is filled with oxygen free blood returning from the body. While the left atrium receives oxygen rich blood from the lungs. 2: After the atria fill an electrical impulse causes them to contract forcing open valves that lead to the ventricles. 3: The same electrical impulse causes the ventricles to contract about a tenth of a second later pushing the blood through another set of valves that lead to the lungs and the rest of the body. 4:The ventricle relax causing the valves to snap shut which causes the dub sound in the heartbeat. This allows the atria to fill with blood and the process repeats itself.
Need for Artificial Heart: Heart disease is the number one cause of death for both men and women in the United States Currently 17 million people die from heart disease each year. It’s estimated that 20,000 people worldwide are in vital need of a transplant each year. Over 25% of patients waiting for a transplant die before they can receive an organ....continue reading
Oct. 18: Total Artificial Heart patient Troy Golden (middle) with his wife Darrla and Dr. Douglas Horstmanshof, heart failure cardiologist and co-director of the INTEGRIS Advanced Cardiac Care program, prior to being discharged from the hospital using the Freedom™ portable driver
Oklahoma Pastor Gives 1st Sermon Since Receiving SynCardia’s Total Artificial Heart November 30, 2010
Freedom® Portable Driver Allows Troy Golden to Be Discharged Home and Deliver Message of Hope and Faith to Congregation
TUCSON, Ariz.--(BUSINESS WIRE)--Before heart failure stopped him in his tracks, 45-year-old Troy Golden (photo) had preached every Sunday for the last 12 years at the New Life Assembly of God in Geary, Okla. Too sick to preach for the last six months, on Sunday, Nov. 21, Golden gave his first sermon since receiving the SynCardia temporary Total Artificial Heart and being discharged home using the Freedom® portable driver.
“The hope and faith and trust that I have, comes from a Lord who has given me new life,” said Golden. “It’s wonderful… I just can’t express how wonderful and awesome it has been to preach again.”
In the crowd at the rural Oklahoma church were Golden’s cardiovascular surgeon, Dr. James Long, and his heart failure cardiologist, Dr. Douglas Horstmanshof, both co-directors of the Advanced Cardiac Care program at INTEGRIS Baptist Medical Center.
Golden is participating in an FDA-approved Investigational Device Exemption (IDE) clinical study of the 13.5 lb Freedom driver, the first portable driver designed to power the SynCardia Total Artificial Heart both inside and outside the hospital. The IDE clinical study is designed to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be safely used at home.
“It boggles my mind that I was hooked up to a 418-pound machine, and here’s a little, 13-, 14-pound machine doing the same thing,” said Golden. “It’s unbelievable.”
Currently, the only FDA-approved driver for powering the Total Artificial Heart is the 418-pound "Big Blue" hospital driver. Patients are confined to the hospital while supported by Big Blue.
Promising technology inspired by nature November 28, 2010
Artificial heart pumps and valves have been around for a while. One of their continuing issues is causing tissue scaring, unnatural turbulence and cell damage. That is partly because the materials they are made from are rigid compared to natural organs. The resulting management of fluid pumping is also less than optimal. Jellyfish inspire flexible pumps
“We’re really lucky,” says Nawroth. “The Reynolds numbers we see in the movement of jellyfish of different sizes and ages are in the right range as what we need for medical applications.”
As a step towards creating flexible pumps, Nawroth is studying how jellyfish shape and tissue composition adapt to the demands imposed by flow conditions at different Reynolds numbers.
Jellyfish at millimeter scales, for example, exploit the small layer of water that adheres to their surface as they move and use it as additional paddle at no extra cost.
Further, a clever arrangement of multiple pacemakers within the jellyfish body allow for a reliable yet tunable pumping mechanism. In the future, Nawroth plans to use this practical understanding to help design a whole spectrum of flexible pumps that are optimized for different tasks and conditions.
Innovations in Heart Surgery: An Interview with Bartley Griffith, M.D.
The heart pumps 2,000 gallons of blood a day. I guess most of the time our hearts can handle that very well, but if somebody has a condition known as heart failure, their heart isn't pumping as well as it should. Is that true? It's so true. In fact, congestive heart failure is the scourge of America, with more than 5 million cases every year in this country. What is heart failure? It's a failure of the heart muscle to squeeze effectively. So it's kind of a breakdown of the pump's pumping ability. Why is that so common today? It's common because we have lots of things that cause the heart to become diseased and swollen. The most prevalent would be heart artery blockages. If you have enough blockages and enough heart attacks, eventually the heart runs out of cylinders, if you wish, or power to make the blood go through. The other common cause is high blood pressure. Untreated, hypertension is a very big problem and causes the heart eventually to poop out. Are there good medicines people can take for heart failure to increase the pumping ability of their heart? You bet. The mainstay of heart medicines include medications that cause water to pass through our bodies, medications that dilate the blood vessels and make the heart more efficient in its contraction, and finally medications that just affect the muscle directly, make it kind of calm down and be more efficient. And for most people those are effective? These are the mainstay of therapy for most people, and they have made a huge difference.
UM cardiac surgeons have put the first four VentrAssist heart pumps in U.S. patients.
University of Maryland Heart Transplantation Program Video
Overview: In this ten-minute video, Dr. Bartley Griffith, Chief of the Division of Cardiac Surgery and Director of Heart and Lung Transplantation at the University of Maryland Medical Center, provides an overview of the Heart Transplantation Program offered at UMMC. Dr. Griffith discusses the advances that have been made in heart transplantation at UMMC over the years and how these advances have led to improved patient outcomes. He also talks about all of the different factors that must work together for a successful heart transplant, including a smooth transfer to the intensive care unit (ICU) and adequate patient education before discharge.
Then there are people with severe heart failure who don't have a great prognosis so they will come to someone like you, a heart surgeon, for some other options, right? Right. One of the things I spent a long time on is treating the hopelessly ill and patients with end stage heart disease, who really need something more than what medicine can give them. You can't take a pill usually when you get to me. Some patients, in spite of good care, end up with a swollen heart that does not respond to medication.
At this point there only two options -- a heart pump, which I will talk about in a minute, and a heart transplant, where you remove it and put a human donor heart in place. The problem with heart transplants is that there are too few donors available. The maximum number of heart transplants we’ve ever been able to do in this country in a year is around 2,000, and there may be 50,000 people every year who might qualify for heart transplants.
Do heart transplants work well if somebody is lucky enough to get a donated heart? You bet. People would be amazed to know that a heart transplant is not meant to give patients just a few weeks of life -- it's really treatment. It's more than 50% of patients who are living seven to 10 years after a heart transplant, and my longest is living more than 20 years.
Because of the shortage of donated hearts, I know you are a pioneer in working on heart pumps (artificial hearts). Can you tell us a little bit about what's available today?
A lot has happened in the heart pump development. I used the first total artificial heart that was part of the Barney Clark story -- a very long time ago in my mind -- back in the early '80s. Since that time we developed the idea that again smaller is better, and again all of the cardiac surgical tools are getting smaller. We adopted a whole new class of pumps that run like a turbine engine and are working on them in our laboratories at the University of Maryland.
The Jarvik pump is inserted inside the pumping chamber of the heart.
One of these is called a Jarvik pump and it goes right inside the pumping chamber of the heart and contains a turbine and it runs continuously.
There are other types as well, one of the most interesting of which is the Ventracor [also called VentrAssist] pump. We had the privilege of putting the first four of these in patients now in the United States. It's a pump that runs continuously but the pump is designed a little differently in that it has no bearings and there is nothing that the spinning part touches. It just basically floats in the flowing blood and we think that means the pump will be more durable. It may last 25 years.
Abstract: A pneumatic pump comprises two coaxial cylindrical pumping chambers, each enclosing a piston connected to the other through a partition by a tube, thereby forming a monolithic piston assembly that is driven axially by a common electrical actuator providing reciprocating motion. The volume in the bottom chamber is selected as needed to provide the desired pressure in the left ventricle of an artificial heart driven by the pump. The diameter of the tube connecting the pistons is selected such that the stroke volume of the top chamber is reduced with respect to that of the bottom chamber as needed to match the reduced pressure requirements of the right ventricle of the artificial heart. Check valves are used in each chamber to ensure venting of excess pressure during the blood ejection phase and to limit the vacuum during the fill phase.
HeartWare defends heart pump study against Thoratec November 18, 2010 By Debra Sherman
HeartWare investigator defends research
CHICAGO, Nov 18 (Reuters) - A rivalry between HeartWare Inc (HTWR.O) and Thoratec Corp (THOR.O) erupted into a high-stakes battle this week at the world's biggest annual cardiology meeting, where the medical device makers argued over research showing an advantage to HeartWare's implantable heart pump.
HeartWare released a study at the American Heart Association meeting on Sunday, showing that 92 percent of patients survived with the HeartWare device or received a heart transplant after 180 days. [ID:nN14200498]
The study also suggested that one of the biggest side effects of heart pumps, gastrointestinal bleeding, was considerably less with HeartWare's device than with Thoratec's pumps.
Use of the HeartWare device also resulted in fewer infections, the other big problem with such devices, than reported in Thoratec's earlier clinical trial.
Shares of HeartWare surged more than 20 percent to record levels on the data as investors saw the study boosting its chances for U.S. approval for the device, while Thoratec stock lost 20 percent of its value. [ID:nSGE6AE0ZI]
Thoratec fought back on Tuesday, when its Chief Executive Gary Burbach held a lunch with analysts and said that HeartWare's researchers did not make fair comparisons and that the study's results were skewed.
Dr. Keith Aaronson, a cardiologist at the University of Michigan Medical Center, was lead investigator of the HeartWare study, showing how its pump -- known as a left ventricular assist device -- worked in advanced heart failure patients who were waiting for a transplant.
He defended the study's findings in an interview with Reuters, saying that while it was not a head-to-head comparison of the two devices, he used comparable clinical data from other published studies to draw conclusions. "I don't want to get into.....continue reading
HeartWare's implantable heart pump meets study goal November 14, 2010
(Reuters) - HeartWare International Inc's implantable device heart pump used in patients with advanced heart failure who were awaiting a heart transplant, met its goal in a major study.
The data, presented at the annual meeting of the American Heart Association in Chicago this week, showed that 92 percent of patients whose hearts were too weak to sufficiently pump blood, survived with the pump or received a heart transplant after 180 days, meeting its main goal.
Nearly one year after implantation of the device -- about the size of a golf ball and weighing about 5 ounces -- 91 percent had survived, compared with 86 percent in the control group, a difference that was not considered statistically significant.
Results of the study of 140 patients at 30 U.S. medical centers were comparable to other pumps that already are approved as a bridge to transplant. The HeartWare left ventricular assist device, or HVAD as is known, already is approved in Europe....continue reading
Heart Booster Pumps Used For First Time In US, Rivals The Artificial Heart November 12, 2010
The Bluhm Cardiovascular Institute of Northwestern Memorial Hospital recently implanted a patient with two of the smallest experimental ventricular assist devices (VADs) currently available for study in humans. VADs are designed to assist either the right (RVAD) or left (LVAD) ventricle, or both (BiVAD) at once. This is the first time that two Heartware™ VADs have been implanted in the left and right ventricles anywhere in North America—a “game changer” in the realm of heart assist devices according to Patrick M. McCarthy, MD, chief of the hospital’s Division of Cardiac Surgery and director of the hospital’s Bluhm Cardiovascular Institute
“The world doesn’t need the artificial heart anymore,” said Dr. McCarthy, who is also the Heller-Sacks Professor of Surgery at Northwestern University Feinberg School of Medicine. “The goal is total support of the heart. This biventricular approach achieves that without cutting out the patient’s own heart, which is what happens with artificial heart implants.”
According to Edwin C. McGee, Jr. MD, surgical director for the Bluhm Institute’s Heart Transplant and Assist Device program and the lead cardiac surgeon who performed the implant, when the patient, 44-year-old James Armstrong, was transferred to Northwestern Memorial just weeks ago, he was near death with an aggressive state of myocarditis. Myocarditis is a severe inflammation of the heart tissue that—in some rare cases—can be fatal when unaddressed.
Only about a dozen times before in Europe had the twin implant of the small Heartware™ VAD been performed, and now the approach would be Armstrong’s best chances for survival. The Heartware™ VAD is under trial in the U.S. as an LVAD....continue reading
LabVIEW Control System Assures Artificial Heart Does Not Skip a Beat Posted: November 12, 2010
"The LabVIEW programming environment was the clear choice for this project due to its ease of use and flexibility."
An implantable ventricular assist device (VAD) is a pneumatically controlled device (pump) used to assist a patient’s ailing heart until a donor heart becomes available for a transplant. A closed-loop control system had to be developed to use during reliability testing of a new pump design and to enable the fine-tuning of a new control algorithm. A laboratory version of the system controlled eight pumps, uninterruptedly, for a period of over six months while a portable version of the same system was used in field validation trials on animals. NI LabVIEW software running on a laptop controlled a VAD that assisted the natural heart rhythm of a test subject for a period of up to 45 consecutive days. The experiments conducted with this system provided critical data during the design verification and validation process for the new pump, thereby obtaining valuable information necessary for the FDA approval process. To date, Thoratec has received permission from the FDA to begin clinical trials on human subjects.
Pneumatic Implantable VAD
A pneumatic implantable VAD system consists of three major components: a blood pump, two cannulae and an external drive console. The blood pump is connected to the heart with two connecting tube cannulae – one providing inflow and the other providing outflow. The external drive console provides alternating pulses of vacuum and pressure to fill and empty the blood pump and maintains control of the pump by using various control algorithms running on a microcontroller.
An infrared proximity sensor mounted inside the pump detects when the pump is filled with blood and sends a signal to the driver to initiate the empty cycle. In essence, the VAD is a closed loop control system with one analog input, the proximity sensor, and one digital output, the signal that triggers the console to empty or fill the pump. The fill/empty cycle of the pump runs at a rate of about one second, whereas the control loop for the entire system runs at a rate of four milliseconds. Therefore, strict timing must be maintained by the console to ensure this artificial heart system doesn’t skip a beat.
Thoratec Corp. of Pleasanton, CA is a leading manufacturer of VAD systems approved by the United States Food and Drug Administration (FDA). During the development of this new implantable VAD, Thoratec needed to test the reliability of the new device and to design new control algorithms that would later have to be programmed into a custom micro-controller circuit. In order to carry out these tasks, Thoratec Laboratories called upon Cal-Bay Systems, a system integrator in Northern California and Select integration partner in the NI Alliance Program, to develop a control system using LabVIEW and National Instruments data acquisition hardware.
Maintaining consistent control of the pump during long-term bench testing and field animal studies was essential. The system had to be robust, yet flexible. Typically, in this type of application, an embedded real-time control system is used to maintain precise closed loop control. But in this particular application, because the pump fill/empty cycle was in the order of one second, the control loop could vary slightly without causing the pump to skip a beat. We decided to implement this system with a regular PC and off-the-shelf hardware and software. The use of a PC-based virtual instrumentation system provided huge savings in cost and allowed us to get the system up and running in a matter of days, not months.
New treatment for heart patients November 10, 2010
Christ Hospital has started offering a new treatment to help patients with end-stage heart failure.
The "ventricular assist device" helps a failing heart pump blood more effectively after it is surgically implanted, the hospital in Mount Auburn said in a statement Wednesday.
It recently became the only hospital in Greater Cincinnati to offer the service, part of Christ's Mechanical Heart Assist Device Program.
Generally, the devices are implanted to provide a bridge to transplantation, a bridge to recovery or to help improve quality of life for a patient who does not qualify for a transplant.
In past years, the only treatment option for end-stage heart failure was a transplant, but only about 2,000 Americans of the 50,000 a year who need a heart transplant will get one, the hospital said.
"Mechanical heart assist devices are emerging as the newest and most promising treatment options for these patients," said Santosh Menon, medical director of the program.
The device pulls blood from the left ventricle and pushes it into the aorta, the large artery that circulates blood to the body and head. That keeps the heart moving as the device assists it in circulating blood to other vital organs. Source: Cincinnati.com
This illustration shows a new type of heart pump inserted with a catheter to improve the survival rate for infants undergoing a series of surgeries to correct a deadly birth defect
New heart pump to provide temporary assist for infants, adults November 9, 2010
The researchers are developing a "viscous impeller pump" for children born with univentricular circulation, a congenital heart disease that is the leading cause of death from birth defects in the first year of a child's life, said Steven Frankel, a Purdue University professor of mechanical engineering. The innovation also might be used for temporarily treating adults with the disease.
The human heart normally contains two pumps, or ventricles: one circulates oxygenated blood throughout the body, and the other, less powerful, ventricle circulates deoxygenated blood to the lungs.
Babies born with the defect have only one functioning ventricle, but French surgeon Francois Fontan discovered more than three decades ago that the infants could survive on a single ventricle by restructuring the configuration of blood vessels called the inferior vena cava and superior vena cava. The infants must have a series of three open heart surgeries performed over a period of months or years because they are not able to survive the shock of all three surgeries at once.
At least 30 percent of the babies do not survive the surgeries, called the Fontan procedures.
To improve the survival rate, Mark Rodefeld, a medical doctor and associate professor of surgery at the Indiana University School of Medicine, proposed in 2003 to provide a mechanical pump to assist the heart during surgery.
Steven Frankel, a Purdue professor of mechanical engineering, is creating a new type of heart pump for infants born with univentricular circulation, a congenital heart disease that is the leading cause of death from birth defects in the first year of a child's life. Such an innovation would make it possible to perform all three surgeries at the same time, while also providing a temporary heart-assist technology for adults who've had the surgeries, Frankel said.
"A big advantage of this pump is that it gets delivered through the skin with a catheter without open heart surgery," said Frankel, who is working with Rodefeld and other researchers at the IU School of Medicine, the University of Louisville and the Rose-Hulman Institute of Technology's Rose-Hulman Ventures, which is developing a prototype of the pump.
INTERVIEW-Carmat says needs more cash for artificial heart November 9, 2010 By Caroline Jacobs and Noelle Mennella
PARIS, Nov 9 (Reuters) - French group Carmat will likely need to raise at least 20 million euros ($28 million) in two years to further develop and market its artifical heart.
Carmat, which fetched roughly 15 million euros in its July initial public offering, aims to implant its 900-gramme fully automated heart in a patient for the first time next September or October, chief executive Marcello Conviti said on Monday.
The company sees a big market for its 160,000 euro hearts -- saying only 4,000 patients per year get a donor heart while demand is for 100,000.
"The current funds will get us to the first clinical trial results in the first quarter of 2012 and after that we will return to the market to get the means to accelerate and continue our trials and to set up the commercial part," Conviti said.
Developed by a team of engineers from aerospace group EADS, biologists and conceived by French heart surgeon Alain Carpentier, Carmat's heart mimics the heart muscle's contraction with two micro pumps, one for each ventricle, or heart chamber, that make the blood flow.....read more
Realization of Automatic Measurement and Bionic Control of Rotary Heart Pumps K.X. Qian, T. Jing, L. Li
Abstract- The comfortability of the receiptor with a left ventricular assist pump becomes more and more important along with the daily prolonged survival. Thereby it is necessary to achieve automatic measurement and bionic control for heart pump. The key-point is to improve the sensitivity of flow rate change after the pressure head variation in the pump, so as to maintain the flow rate balance between the left ventricular assist pump and the natural right ventricle
This paper presents the measurement of the pump flow and head by computation from motor driving parameters, and the control of the pump imitating the natural ventricle, much more sensitive than available constant voltage and constant RPM control.
Modeling and Identification of an Intra-Aorta Pump Chang, Yu; Gao, Bin
Abstract: The intra-aorta pump is a novel left ventricular assist device (LVAD) that assists the heart without the need for percutaneous wires and conduits. It is implanted between the radix aortae and the aortic arch to avoid damage to the aortic valve.
To predict the mean pressure head and blood flow, a nonlinear lumped parameter model, which does not need the parameters of the circulatory system, is established. The model includes a speed-controlled current source, an internal resistor, and an inductance for simulating the pressure–flow rate relationship. The speed-controlled current source is used to represent the blood flow caused by the kinetic energy from the impeller, the internal resistor is used to stimulate the resistance character of the radial clearance of the intraaorta pump, and the inductance is used to model the inertia of the blood that passes through the radial clearance.
Each part of the model has clear physical significance, which is helpful for extending the model to other blood pumps. It can generate all status of the pump from suction to pulmonary congestion. The model is summarized as a function of the pressure head, the blood flow, and rotational speed of which the values of parameters in the model are determined by experiment. The model and prediction method are tested experimentally on an in vitro mock loop. A comparison of the predicted pressure head obtained from our model with experimental data shows that our model can predict the differential pressure accurately with error <5% for all experimental conditions over the entire range of intended use of the intra-aorta pump.
Thoratec 3Q EPS Up 21% Behind More Gains For Heart Pump October 29, 2010 By Jon Kamp, Of DOW JONES NEWSWIRES
Thoratec Corp.'s (THOR) third-quarter earnings rose 21% as the heart-pump maker continued to expand sales of its key product, an implantable heart-pumping device.
The Pleasanton, Calif., company also backed its financial guidance for the year.
Thoratec won Food and Drug Administration approval in January to sell " HeartMate II" pumps for patients who aren't eligible for transplants, opening an important new market for those devices. Before that approval, the pumps were approved for only patients awaiting transplants, but that is a smaller market.
The company posted third-quarter earnings of $14.3 million, or 24 cents a share, down from $11.8 million, or 21 cents a share, a year ago. Excluding share-based compensation expenses and other items, the company said per-share earnings rose to 32 cents from 21 cents. Sales from continuing operations--the company isn't counting sales there from a business it wants to sell--rose 40% to $91 million....read more
Artificial heart recipients break five-year survival record
Artificial heart recipients break five-year survival record October 28, 2010
Three patients who received artificial hearts at the Hannover Medical School (MHH) five years ago have broken a European survival rate record. Only two other artificial heart recipients in the US have lived longer with such a device.
Deputy director of the MHH heart clinic Professor Martin Strüber says that when he began the clinical trial for the 375-gramme “Heartmate II” he could only hope for such a successful outcome for his patients.
“Five years ago we couldn’t be certain that a life without a pulse would go well over the course of years and the other organs would adapt,” he says.
In that time, each 12-centimetre titanium heart has pumped some 15 million litres of blood through each man's body.
“I think they could pump a good ten years, but the tubes would be a problem, for example,” Strüber adds.
When Nino Wolfram received his implant, he was 21-years-old and a long donor list meant there was no alternative for replacing his weak heart. At the time doctors thought it would be a temporary measure until a donor appeared.
“I’m happy that I got an artificial heart, because otherwise I’d no longer be alive,” he says.
Still, the device is only a “plan B” solution, though the clinic says it is working to make it a first-choice treatment in the face of ever longer transplant waiting lists for real hearts. Some patients wait for up to five years to get new hearts – time that many don’t have.
The MHH has now put artificial hearts into 100 patients, they say....continue reading
2 U.S. Hospitals Begin Certification to Implant SynCardia’s Total Artificial Heart October 28, 2010
Brigham and Women’s Hospital and University of Iowa Hospitals and Clinics to Become Newest SynCardia Certified Centers
TUCSON, Ariz.--(BUSINESS WIRE)--SynCardia Systems, Inc. (http://www.syncardia.com/) announced today that Brigham and Women’s Hospital in Boston, and University of Iowa (UI) Hospitals and Clinics in Iowa City, Iowa, have begun certification to implant the SynCardia temporary Total Artificial Heart. Brigham and Women’s will complete Phase I of certification on Nov. 1 & 2, and UI Hospitals and Clinics completed Phase I on Oct. 21 & 22.
Brigham and Women’s Hospital: Brigham and Women’s is ranked #7 among the Best Hospitals in Heart and Heart Surgery by U.S. News & World Report. The heart transplantation program is the oldest and largest in New England. Since performing the region’s first heart transplant in 1984, Brigham and Women’s has performed over 500 heart transplants, more than any other program in the region. The hospital now follows the largest population of patients surviving heart transplantation.
UI Hospitals and Clinics: In 2009, UI Hospitals and Clinics performed 18 heart transplants and achieved a one-year survival rate of 100%. The hospital’s median waiting time for a heart transplant is approximately 9 months. Since 2009, UI Hospitals and Clinics have implanted 22 ventricular assist devices and have discharged 18 of these patients to enjoy life at home.
Currently, there are 13 SynCardia Certified Centers in the U.S., with an additional 9 U.S. hospitals undergoing certification. Around the world, there are 33 SynCardia Certified Centers, with an additional 15 international centers undergoing certification. SynCardia Certified Centers are located in Germany, Italy, France, Australia, Russia, Austria, Turkey, Sweden and Canada and the U.S.
Tommy "Smitty" Smith was matched with a donor heart last week
Needham Man Finds Heart Donor, Now Resting Post Surgery posted: October 20, 2010
Tommy Smith is currently recovering from a heart transplant that was conducted in Boston last week.
For over a year, Tommy Smith lived with a left ventricular assist device, a device that helped pump blood through his body after he suffered a sudden heart attack at the age of 50. In between pumps from the artificial heart, Smith suffered physical setbacks and spent much time in the hospital as he patiently waited for a transplant.
For patients on a transplant waiting list, salvation comes down to a fifty-fifty chance as two people are called in for every one organ that becomes available. Should a person be called in as a potential recipient, they must then wait as their information is compared to the other person in line. If the first person is deemed not a good match, they are sent home and begin the waiting game anew.
"It's an emotional rollercoaster when they call you in and then you get sent home," said Tommy's wife, Linda.
Linda related that her husband was called in twice in one day last month, only to be sent home both times. The couple's luck changed, though, when Tommy was called into the hospital on Columbus Day. Tommy was the second patient out of two considered for a potential heart, but after waiting for six hours, the Smiths were again sent home....read more
With device, Geary man is able to await new heart at home October 19, 2010
Update on Troy Golden:
As a pastor, Troy Golden preaches of miracles and resurrection. As a patient, Golden lived a near-miracle and resurrection as he left the hospital without a real heart.
He pushed a gray backpack on wheels that thumped like a loud heartbeat. The pack contains an investigational portable driver that powers the two-chambered artificial heart in his chest. Now he can wait for a real heart at home in Geary.
He said Monday that he feels good. "I'm ecstatic to go home.
I'm ecstatic that this artificial heart has given me a chance to wait for a heart transplant,” said the 45-year-old pastor and nurse.
"This is almost like performing a resurrection,” said Dr. James Long, Cardiovascular surgeon and Integris Baptist Medical Center advanced cardiac care program co-director. "This is taking someone who was checking out and giving them life, and life abundantly.”
Golden was the sickest of the sick. Doctors asked if he wanted to join the national clinical trial and receive the total artificial heart and investigational driver.
On September 15, he became the first in this region to be implanted with a total artificial heart. Yesterday, Monday October 18, he became the country's second total artificial heart patient to go home with a portable driver....read more
Morrison's Kylie Radford and Richard Poulson with children Baxter and Louis. Picture: Karin Calvert Source: PerthNow
Fashion man Richard Poulson's time bomb heart fixed by robot arms October 16, 2010
ONE of WA's most successful fashion identities is recovering from major heart surgery after doctors discovered he was a "ticking time bomb".
But Richard Poulson, co-founder of the internationally-recognised label, Morrison, was forced to fly to Victoria because his operation couldn't be done in time in WA.
"When I was 18, I was diagnosed with a heart murmur," he said. "Each year since I've been getting it checked. Then I went to my cardiologist two months ago and he said, 'Well, the time has come'. I was on my own and he just told me I needed open-heart surgery.
"The 38-year-old had a mitral valve prolapse - a heart condition that, if severe, can result in cardiac arrest usually resulting in sudden death.
A number of surgeons in Perth were recommended to Mr Poulson who, with wife and business co-owner, Kylie Radford, were this month valued at $42 million in the annual BRW Young Rich List. But he wanted his valve repaired using minimally invasive surgery rather than open- heart surgery......continue reading
The DuraHeart LVAS is the latest-generation rotary blood pump designed for long-term patient support.
Toronto General Hospital First Canadian Center to Implant Duraheart™ Left-Ventricular Assist System as Part of North American Bridge-to-Transplant Clinical Trial October 14, 2010
Terumo Heart, Inc., a wholly owned subsidiary of Terumo Corporation, today announced that the Peter Munk Cardiac Centre, at Toronto General Hospital, has become the first medical center in Canada to implant the DuraHeart™ Left-Ventricular Assist System (LVAS) as part of the study evaluating safety and effectiveness of the DuraHeart Left Ventricular Assist System in bridge-to-transplant patients (SUSTAIN BTT). The SUSTAIN trial is a multi-center, prospective, non-randomized study involving up to 140 patients across North America. The implantation also marks the first time a Canadian patient has been treated with the DuraHeart LVAS.
The study, which was granted unconditional approval in early 2010 by the U.S Food & Drug Administration (FDA), is evaluating the safety and efficacy of the device in helping to support patients awaiting heart transplant who are at risk of death due to end-stage heart failure. The DuraHeart LVAS carries a CE Mark and is currently available for sale in European countries. The company has recently completed clinical trial enrollment for this device in Japan, and has submitted its Destination Therapy (DT) Investigational Device Exemption to the FDA, which is a first step in the process of obtaining approval to begin its DuraHeart DT Clinical Trial in the United States....read more
Troy Golden, an artificial heart transplant patient, eats lunch at Hideaway Pizza on the N.W. expressway with nurses and doctors. It was his first outing outside the hospital in three months.
Artificial Heart Transplant Patient Takes First Trip Outside Hospital October 13, 2010
Troy Golden, the first Oklahoma man to have his heart removed and replaced with a total artificial heart on September 15, took a trip outside the hospital for the first time in three months.
The Geary pastor, was born with a genetic condition that destroyed his heart. With no transplant available, doctors at INTEGRIS Baptist Medical Center performed the surgery giving the 45-year-old a device that will keep him alive until a heart becomes available.
Tuesday, Golden took a lunch break at Hideaway Pizza, eating with a table full of doctors and nurses and with his portable heart pump in tow. The field trip of sorts was part of his physical therapy.
"I'm still building up my strength so that is an adjustment. I'm not able to do exactly what I want to do yet but I'll get there," Golden said.
He hopes to be released from the hospital in a few days and said he can't wait to sleep in his own bed.
Next-gen mechanical heart debuts in Canada October 12, 2010
In 2007, Marva Lorde of Mississauga, Ontario, suffered a heart attack that resulted in 10 days in the intensive care unit, angioplasty, and pacemaker implantation, only to be followed by another cardiac arrest in 2008.
Now 61, she has become the first person in Canada (and among only a handful in the world) to be implanted with a longer-lasting left ventricular assist device (LVAD). The device, called DuraHeart by Terumo Heart, was first implanted in clinical trials in the U.S. in 2008 and is also being used in Germany. It's designed for long-term cardiac support to reduce the risk of common mechanical heart complications that range from device failure to strokes and infection.
The device's central pump is powered by magnetic levitation technology; its moving parts rely on magnets instead of bearings, and enables blood to flow through the pump more smoothly, resulting in less wear and tear and, ultimately, a longer-lasting device.
Ideally, this next-gen LVAD will eliminate the need for second LVADs altogether, thereby reducing surgeries, recovery times, and resulting complications. So far the longest-living recipient of the DuraHeart is a 66-year-old woman in Germany, who celebrated four successful years with the device in May.
Life and death in the age of the bionic heart REUTERS - Brian Snyder October 2010 special report
A new generation of heart devices is giving new hope to patients. Their use has increased 10-fold since January but ethical quandaries loom: When is it appropriate to disconnect the device and let a patient die?
Former Vice President Cheney Hits the Road for First Public Events Since July Heart Surgery October 11, 2010
Former Vice President Cheney is starting to emerge in public again after spending the summer recuperating from heart surgery. Over the weekend Cheney participated in an event at the Bakersfield (CA) Business Conference where he took questions from his wife, Lynne. “She's been my nurse, my negotiator with the medical community, and in return for all of that great help she's given me, today I've agreed to let her interview me," the vice president said according to news reports. The former vice president appeared “frail” according to reports from the event and in pictures he appeared noticeably thinner than his White House days.
Cheney has been on the mend since early July when he underwent a procedure to implant a Left Ventricular Assist Device (LVAD) into his heart to treat his recurring heart disease. He said at the time that it became clear that he was "entering a new phase of the disease" when he began to "experience increasing congestive heart failure."
The California event was Cheney’s second appearance this month - last week he spoke at a closed press event for the Council of Insurance Agents & Brokers in Colorado Springs.
A DuraHeart patient wears the accompanying battery pack while atop a mountain in Germany. Image courtesy of Terumo Heart.
Primed pump: New heart device puts Terumo in middle of market share battle October 10, 2010
Terumo Heart Inc., an Ann Arbor-based medical device company, plans to hire another 20 workers in 2011 and subcontract additional work to local companies to speed development of DuraHeart II, a device designed to extend the lives of heart failure patients, some of whom are waiting for life-saving heart transplants.
“DuraHeart II is a smaller version of our current pump (DuraHeart Left-Ventricular Assist System),” said Terumo Heart CEO William Pinon. “We hope to file for an IDE (investigational device exemption) trial at the end of 2012 instead of 2013. We have an aggressive timeline.”
More than 22 million people worldwide suffer from heart failure, and 1 million new patients are diagnosed each year. In the U.S., more than 4,000 Americans wait for a heart transplant each day, but only 2,100 receive them each year because of organ shortages. Hundreds of people with heart failure die during their wait.
“There are 100,000 people worldwide who are ineligible for heart transplants for various health reasons,” Pinon said. “These people can benefit from a mechanical pump and keep it in forever.”
Because of demand for the devices, Terumo Corp., the company's Tokyo-based parent, has “set financial targets for us to meet” and designated Terumo Heart to be one of its five growth areas over the next 10 years, Pinon said.
“This market is tremendous with 30 percent (annual) growth estimates,” Pinon said. “Analysts show a $1.2 billion to $2.2 billion market in the next five to seven years, up from about $240 million now.”....read more
New Type of Artificial Heart Helps Save Lives Waiting For Transplant October 9, 2010 Surgery Blog By Jennifer Heisler, RN, Surgery Guide
A new heart pump is being studied in the United States. Commonly known as an "artificial heart" the new pump, called The Berlin Heart, is not commonly available but is being used in some heart transplant patients who would not otherwise survive long enough to receive a donated heart.
Until the heart pump is approved by the FDA, it won't be available except in select cases. The most recent data indicates that 326 pediatric patients have been on the device in the United States.
The Berlin Heart is most commonly used in young children less than 2 years of age, when ECMO is not appropriate. The device is considered a "bridge" to transplant, which means it supports the patient who would otherwise die of cardiac issues until a donor organ is obtained.
Boy Becomes First Human To Live With Permanent ‘Robot Heart’ October 4, 2010
Until now, all other artificial heart transplants were just temporary relief. A 15-year-old Italian boy with Duchenne syndrome became the first person to receive a permanent artificial heart.
The illness was wasting his muscles away and prevented him from receiving a heart transplant, causing doctors in Rome to insert the 4cm long electrically activated hydraulic pump “heart” in his left ventricle. A plug behind his left ear and a battery attached to his belt powers the heart, which will gift him another 20-25 years of life that he wouldn’t have had without this operation.
If you compare the unnamed boy’s 90g heart with the first ever artificial heart from 1969, you can see just how far the medical world has progressed in those 41 years. The photo above shows the first ever artificial heart, which was placed inside a man’s heart for 64 hours while he waited for a donor heart.
Bridge to a new life October 1, 2010
A pediatric heart pump used at Nationwide Children's Hospital for the first time sustained 15-month-old Avrie Nelms until a donor heart became available.
The smiles Avrie Nelms' mom and dad wear say more than any doctor could hope to. For the heart experts at Nationwide Children's Hospital, it's big news that they used a pediatric heart pump for the first time. The German-made pump, called the Berlin Heart, is their current best hope for keeping children alive for the months that can elapse while their patients wait for transplants.
For Melissa and Aaron Nelms, the pump is but one thing for which they are so grateful.
Surgeons implanted two pumps (one for each side of the heart) in 15-month-old Avrie after her heart stopped early last month. Avrie already was on the transplant list, but nobody knew how long they'd have to rely on the Berlin Heart while they waited for a donor.
Eight days later, the news came.
"I was overwhelmed with joy, and at the same time sad knowing another family lost their child," Mr. Nelms said. Now, 18 days after surgeons placed that heart inside Avrie's chest and watched as it began to beat with strength and efficiency, her parents are beginning to think about going home to Delaware and about how excited Avrie's 4-year-old sister, Macie, will be to see her.....continue reading
Florida Hospital physicians implant Central Florida's first Ventricular Assist Device (VAD)
Sunshine Heart(R) to Develop Smaller Next Generation Controller for Its C-Pulse(R) Heart Assist System EDEN PRAIRIE, MN -- (Marketwire) -- September 29, 2010
Sunshine Heart Inc. (ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that it has engaged two leading industrial design and software firms to develop the next generation electronic power and software driver for its C-Pulse® Heart Assist System. By miniaturizing the separately-housed controller and driver and combining them into one compact unit, Sunshine Heart is broadening future clinical and commercialization opportunities for C-Pulse.
The Company has entered joint development programs to develop a smaller, quieter and lighter single-control system for use in the U.S. pivotal clinical trial, which is expected to commence once the FDA approved IDE feasibility study is completed. The new C-Pulse design will integrate the power driver and battery pack into one unit, significantly reducing the size and the weight of external components. These external design changes will greatly improve mobility and comfort for the patient without altering C-Pulse implantable components or the way in which the device functions inside the body. The new single unit will also feature a number of software enhancements that are intended to allow medical professionals to collect additional data to improve patient management.
Sunshine Heart Chief Executive Officer Dave Rosa said, "Due to its small internal components, the C-Pulse can ideally be implanted through minimally invasive procedures as opposed to a full sternotomy procedure. Now, with the redesign of C-Pulse external components, the system will be more ergonomically appealing and comfortable for patients. Our ultimate goal is to make the C-Pulse a fully-implantable system which, much like a pacemaker, can be easily implanted and effortlessly managed by patients."
The C-Pulse heart assist system is designed to treat patients suffering from the debilitating effects of moderate to severe heart failure caused by a failing left ventricle (the left heart chamber). The C-Pulse System features a unique balloon counterpulsation technology that is designed to assist the left ventricle by reducing the workload required to pump blood throughout the body. In addition, it increases blood flow to the coronary arteries. Combined, these potential benefits may help reverse the heart failure process or maintain the patient's current condition, thereby preventing the need for later stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants.
Grant to help CII researchers develop pediatric heart pump
Grant to help CII researchers develop pediatric heart pump by UofL: September 29, 2010
Researchers at the Cardiovascular Innovation Institute have received a $2,027,059 grant from the National Institutes of Health to further develop an implantable pump that could dramatically improve the lives of patients with single ventricle heart disease.
UofL biomedical engineer Guruprasad Giridharan, PhD; Indiana University pediatric surgeon Mark Rodefeld, MD; and Purdue University mechanical engineer Steve Frankel, PhD, lead the project.
“Single ventricle heart disease is the leading cause of death from any birth defect in the first year of life,” said Giridharan, who is UofL’s principal investigator. “The children usually require three major surgeries in the first few years of life to re-route blood flow and lighten the workload of the single ventricle, which pumps blood both to the body and lungs.”
The implantable pump is designed to deliver blood to the lungs and assist the single ventricle, improving the child’s circulatory status, he said.
“We have created pump prototypes of this novel and simple assist device,” Giridharan said. “The funding from the NIH will enable improvement of the prototypes that will hopefully take it that much closer to implantation in humans.”...read more
Innovative Artificial Heart Keeps Baby Alive Posted: September 28, 2010
Berlin Heart Used For First Time In Tennessee
Doctors at Vanderbilt Medical Center say they have experienced a miracle in one special patient. Nathan Roberts was born with congestive heart failure. Every day he waits for a new heart, but during his wait, he's made history and broken barriers that could save other babies.
When he was nine days old, doctors told Nathan's mom, Mandy Roberts, that her son had congestive heart failure and needed a new heart. Nathan was placed on the transplant list, and in May he was put on life support. “His health was horrible at the time. Absolutely horrible,” said Mandy Roberts.
Doctors opted to use what’s called a Berlin Heart pump. “This is the only artificial heart small enough for babies, so there is no other option,” said Vanderbilt pediatric cardiac surgeon Karla Christian. “It is doing the work of the left side of the heart.” “We were a little nervous to be honest, but just knowing that it would change his life, we completely trust the doctors here,” said Roberts.
For four months, the special heart has kept Nathan alive. “He's a completely different baby. I mean, looking at the pictures then and how he looks now, he is a completely different child,” said Roberts. “He's our miracle baby because he's our first for the institution and the first for the state (to use the Berlin Heart,)” said Christian. In the meantime, Nathan's mother is hopeful the Berlin Heart will keep her son alive until a donor is found. “That’s the miracle we're waiting for now. The day we get that phone call and they say we have a heart waiting for you. That’s going to be a great day. It keeps me going,” said Roberts.
Every year, there are about 12 babies at Vanderbilt Children’s Hospital who wait for a heart replacement, just like Nathan.
Artificial heart transplant puts Geary man at medicine's vanguard Posted: September 27, 2010
The heart of a Geary man, 45-year-old Troy Golden, was removed and replaced with an artificial heart. The mechanical heart is designed to keep Golden alive until he can receive a donor heart, doctors say.
Troy Golden was born with a broken heart. But a cardiology team armed with the latest medical technology has fixed it. On Sept. 15, the 45-year-old Geary man became what's believed to be the region's first person to have his heart replaced with the SynCardia Total Artificial Heart.
The implant at Integris Baptist Medical Center in Oklahoma City is one of more than 850 such implants nationwide.
Beginning at birth, the connective tissue in Golden's body came under attack due to a genetic condition called Marfan syndrome. The tissue holds the body together and provides a framework for growth and development. The syndrome can affect body systems including the heart and blood vessels.
Golden began taking heart medication when he was 27 years old. The disease progressed, until he required surgery at age 35. Six years later, he went under the knife again.
"This time, it was a major overhaul," Golden said. "I had an aortic valve replacement, an aortic root repair, a mitral valve replacement and the Maze rhythm procedure on my atrium. Pretty much everything they could do to my heart, they did." This bought him some time, but inevitably the shortness of breath and fatigue returned. He was put on the heart transplant list in January.
Golden is familiar with the transplant process. His younger brother, who also has Marfan syndrome, received a heart transplant 15 years ago. His health is remarkable today. Golden hoped for the same outcome as his brother and began the long wait for a donor heart.
"However, time ran out for Troy," said Dr. Doug Horstmanshof, heart failure cardiologist and co-director of the Integris Advanced Cardiac Care program. "The only alternative to imminent death was a mechanical heart pump. But our experience told us that Troy's heart disease was so bad that a traditional heart pump wouldn't be enough. So we decided to try something different — completely replacing the heart with the Total Artificial Heart."
The heart is the only FDA-approved heart device of its kind.
Heart pump is alternative to surgery Posted: September 23, 2010
Angelo DiMartino, who suffers from congestive heart failure, had a heart pump implanted. His only other treatment option is a heart transplant....read story
(Left) Angelo DiMartino, 79, of Orangeburg shows off his LVAD (left ventricular assistive device) that is used to pump his heart July 20, 2010. Video by Mark Vergari
Cardiovascular Innovation Institute researchers receive over $2 million grant from NIH September 22, 2010
Louisville, Ky. – Researchers in the Cardiovascular Innovation Institute, a partnership between the University of Louisville and Jewish Hospital, in collaboration with researchers at Indiana University and Purdue University, have received a $2,027,059 grant from the National Institutes of Health to further develop an implantable pump that could dramatically improve the lives of patients with single ventricle heart disease.
Single ventricle heart disease is a congenital condition in which one chamber of the heart is either missing or underdeveloped, causing an overwhelming burden on the remaining chamber to pump blood effectively.
The project is led by UofL biomedical engineer Guruprasad Giridharan, PhD, Indiana University pediatric surgeon Mark Rodefeld, MD, and Purdue University mechanical engineer Steve Frankel, PhD. It represents a collaboration between biomedical engineers in the Department of Bioengineering at UofL, who are based at the CII, and UofL's Division of Thoracic and Cardiovascular Surgery.
"Single ventricle heart disease is the leading cause of death from any birth defect in the first year of life," said Giridharan, who is UofL's principal investigator. "The children usually require three major surgeries in the first few years of life to re-route blood flow, and lighten the workload of the single ventricle, which pumps blood both to the body and lungs."
The implantable pump is designed to deliver blood to the lungs and assist the single ventricle, improving the child's circulatory status, Giridharan said.
"We have created pump prototypes of this novel and simple assist device," Giridharan said. "The funding from the NIH will enable improvement of the prototypes that will hopefully take it that much closer to implantation in humans."...continue reading
Orthotopic Total Artificial Heart - Patent 6669726
Abstract: An orthotopic total artificial heart for replacing the human heart comprising a new design of two assembled blood chambers with an original layout between themselves and between their inlet and outlet ports. Such design enables a significantly better space utilization inside the anterior mediastinum than the prior art; realizing the required anatomical fit.
VADs keep hope alive for 'sickest of the sick' Heart assist devices keep the blood pumping for patients who can't get a transplant September 20, 2010 EDMONTON -
Ian Hauck has no pulse, but is very much alive. He wouldn't be, says his mom Kathy, if a ventricular assist device (VAD) wasn't doing the work of the left side of his heart.
Hauck, 20, is one of a very small, but increasing number of people living with heart failure, thanks to a surgically implanted, battery-operated, mechanical pump-type device. The Wainwright man, who has a twin sister, was born with congenital heart defects that were surgically corrected. Everything was fine until a virus attacked his heart two years ago and he lost 40 per cent of his heart function. Hauck became ill and entered the hospital last February. That's where he was when his heart failed in March.
Hauck has Down syndrome (cdss.ca), "but is not a candidate for a heart transplant because of another medical condition", says Dr. Holger Buchholz, director of the pediatric artificial heart program at the Mazankowski Alberta Heart Centre. Before the availability of VADs, that was more or less a death sentence for patients who are "the sickest of the sick." "Now we can say, 'Look, you're not a candidate for transplantation, but we can offer you this therapy,' " Buchholz says. "We expect there will be more patients in this group in future." VADs have been around for at least 20 years in Europe and for 15 years in the U.S., but have only been available for four years in Canada...read more
The HeartWare's Ventricular Assist System
Era of artificial hearts is just a beat away September 20, 2010
700 artificial hearts the size of a golf ball have been transplanted around the world, as well as in Israel for the first time.
The era that the late South African heart transplant pioneer Dr. Christiaan Barnard dreamed of is coming much closer: Forty-three years after he performed the first human heart transplant, 700 artificial hearts the size of a golf ball have been transplanted around the world, as well as in Israel for the first time.
Although the US-made HeartWare device still has to be powered by a battery connected by wires via the abdomen and worn on the belt like a beeper, it won’t be long before the US company presents a model that can be recharged through the chest and can offer a permanent solution to people with diseased hearts.
Prof. Dan Aravot, chief of cardiothoracic surgery at Carmel Medical Center in Haifa, recently implanted the Heart- Ware device into the chest of a 74-year-old kibbutznik named “Ronen” (he asked that his identity not be revealed), who suffered from acute cardioinsufficiency and was not a candidate for a heart transplant because he is nine years older than the maximum age for that procedure.
The $115,000 device – from a new generation of artificial hearts and the most advanced available in the world – was supplied by the hospital, but it hopes to be reimbursed by the man’s health fund or the Health Ministry, as a lessadvanced artificial heart is already included in the basket of health services. A human-heart transplant costs somewhat less than the artificial heart implant if the salaries of surgeons and hospital costs are included.
Aravot told The Jerusalem Post on Sunday that the 140- gram device, inserted during a five-hour operation, allows the patient to get around independently. It has a capacity of 50 cubic centimeters of blood at once and does not destroy the blood cells as it pumps.....read more
Heart Lung machine or Cardiopulmonary Bypass machine- A technique
Cardiopulmonary bypass Posted: September 20, 2010
can be defined as: Bypass of the heart and lungs as in open heart surgery. Blood returning to the heart is diverted through a heart-lung machine (a pump-oxygenator) before returning it to the arterial circulation. The machine does the work both of the heart (pump blood) and the lungs (supply oxygen to red blood cells)
The oxygenator was first conceptualised in the 17th century by Robert Hooke and developed into practical extracorporeal oxygenators by French and German experimental physiologists in the 19th century. Bubble oxygenators have no intervening barrier between blood and oxygen; these are called ‘direct contact’ oxygenators. Dr. Clarence Dennis led the team that conducted the first known operation involving open cardiotomy with temporary mechanical takeover of both heart and lung functions on April 5, 1951 at the University of Minnesota Hospital. The patient did not survive due to an unexpected complex congenital heart defect. The first successful open heart procedure on a human utilizing the heart lung machine was performed by John Gibbon on May 6, 1953 at Thomas Jefferson University Hospital in Philadelphia. He repaired an atrial septal defect in an 18-year-old woman.
Quote from Dr Christiaan N. Barnard, the first surgeon to carry out a successful heart transplant.. “for a dying person, a transplant is not a difficult decision. If a lion chases you to a river filled with crocodiles, you will leap into the water convinced you have a chance to swim to the other side. But you would never accept such odds if there were no lion.”
A Heart-Lung Machine for coronary artery bypass surgery.
Cardiopulmonary bypass (CPB) is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body. The CPB pump itself is often referred to as a heart-lung machine or “the pump”. Cardiopulmonary bypass pumps are operated by perfusionists in association with surgeons who connect the pump to the patient’s body. CPB is a form of extracorporeal circulation. Cardiopulmonary bypass is commonly used in heart surgery because of the difficulty of operating on the beating heart. Operations requiring the opening of the chambers of the heart require the use of CPB to support the circulation during that period.
CPB can be used for the induction of total body hypothermia, a state in which the body can be maintained for up to 45 minutes without perfusion (blood flow). If blood flow is stopped at normal body temperature, permanent brain damage normally occurs in three to four minutes – death may follow shortly afterward.
Extracorporeal membrane oxygenation (ECMO) is a simplified form of CPB, (ebme.co.uk) sometimes used as life-support for newborns with serious birth defects, or to oxygenate and maintain recipients for organ transplantation until new organs can be found.
CPB mechanically circulates and oxygenates blood for the body while bypassing the heart and lungs. It uses a heart-lung machine to maintain perfusion to other body organs and tissues while the surgeon works in a bloodless surgical field. The surgeon places a cannula in right atrium, vena cava, or femoral vein to withdraw blood from the body.
The cannula is connected to tubing filled with isotonic crystalloid solution. Venous blood that is removed from the body by the cannula is filtered, cooled or warmed, oxygenated, and then returned to the body. The cannula used to return oxygenated blood is usually inserted in the ascending aorta, but it may be inserted in the femoral artery.
The patient is administered heparin to prevent clotting, and protamine sulfate is given after to reverse effects of heparin. During the procedure, hypothermia is maintained; body temperature is usually kept at 28ºC to 32ºC (82.4-89.6ºF). The blood is cooled during CPB and returned to the body. The cooled blood slows the body’s basal metabolic rate, decreasing its demand for oxygen. Cooled blood usually has a higher viscosity, but the crystalloid solution used to prime the bypass tubing dilutes the blood.
Cardiopulmonary bypass consists of two main components, the pump and the oxygenator which remove oxygen-deprived blood from a patient’s body and replace it with oxygen-rich blood through a series of hoses. The components of the CPB circuit are interconnected by a series of tubes made of silicone rubber or PVC.
The pump console usually comprises several rotating motor-driven pumps that peristaltically “massage” tubing . This action gently propels the blood through the tubing. This is commonly referred to as a roller pump, or peristaltic pump. Many CPB circuits now employ a centrifugal pump for the maintenance and control of blood flow during CPB. By altering the speed of revolution (RPM) of the pump head, blood flow is produced by centrifugal force. This type of pumping action is considered to be superior to the action of the roller pump by many because it is thought to produce less blood damage (Haemolysis, etc.).
Multiple cannulae are sewn into the patient’s body in a variety of locations
Oxygenator: The oxygenator is designed to transfer oxygen to infused blood and remove carbon dioxide from the venous blood. Cardiac surgery was made possible by CPB using bubble oxygenators, but membrane oxygenators have supplanted bubble oxygenators since the 1980s.Another type of oxygenator gaining favour recently is the heparin-coated blood oxygenator which is believed to produce less systemic inflammation and decrease the propensity for blood to clot in the CPB circuit.
Multiple cannulae are sewn into the patient’s body in a variety of locations, depending on the type of surgery. A venous cannula removes oxygen deprived blood from a patient’s body. An arterial cannula is sewn into a patient’s body and is used to infuse oxygen-rich blood. A cardioplegia cannula is sewn into the heart to deliver a cardioplegia solution to cause the heart to stop beating.....continue reading
Boston Scientific Wins U.S. Backing for Devices for Heart-Failure Patients September 16, 2010
Boston Scientific Corp., the world’s second-largest heart-device maker, won approval from U.S. regulators for expanded use of products to stem the physical decline in heart-failure patients. The U.S. Food and Drug Administration cleared for sale three of the devices, known as CRT-Ds, for patients with less advanced cases of congestive heart failure, the agency said in a statement today. CRT-Ds, or cardiac resynchronization therapy defibrillators, already are approved for severe heart failure.....read more
Sunshine Heart to raise $14.7M September 17, 2010
Global medical device company Sunshine Heart Inc (ASX:SHC) has announced a US private placement and rights issue to raise a total of $14.7 million.
The company is engaged in commercialising C-Pulse, an implantable, heart assist therapy to treat people with moderate heart failure.
Sunshine says it has secured commitments from US based institutional investors for a placement $3.7 million through specialist US healthcare group Summer Street Research Partners.
At the request of US based investors Sunshine says it will also seek a listing on the Nasdaq.
The company will also launch a rights issue at 2.8 cents a share to raise up to $11 million.
The proceeds of the placement and rights issue will go towards, among other things, product development and advancing regulatory trials of C-Pulse in the US.
Sunshine Heart reported a loss for the year to June 30, 2010.......VIDEO
Seattle toddler received this regions first ever mechanical heart implanted in a child under five.
Edwards $30,000 Heart Valve Can Triple Revenue, Lure Buyout Bid September 17, 2010
Edwards Lifesciences Corp. may double annual revenue and become a buyout target with U.S. approval of a $30,000 cardiac valve that can be implanted without open heart surgery.
First, the device, called Sapien, must pass two tests.
Edwards, the world’s biggest heart valve maker, will report data next week that will show whether the device helps frail, elderly people live longer, with fewer hospitalizations, compared with standard therapy. Results from the same study, to be released next year, will demonstrate if it works as well as older treatments in healthier patients.
The device maker’s stock surged 73 percent to $58 in the past year, as investors anticipate positive trial outcomes. If Sapien doesn’t show a survival benefit, one of the study’s two main goals, the stock can tumble to $39, said Suraj Kalia, of Rodman & Renshaw in New York, who recommends selling shares.....read more
The invention relates to an electrical linear drive, in particular for a pump system of an artificial heart, with a movable part and a stationary part, wherein the stationary part is formed by a permanent magnet arrangement and the movable part is formed by a coil arrangement, or vice versa, and wherein the coil arrangement and the permanent magnet arrangement can be moved to and fro relative to each other in an axial direction by means of current passed through the coil arrangement, wherein the coil arrangement (1) is arranged in an axially extending air gap (5) of the permanent magnet arrangement (2) whose magnetic material is magnetized in the axial direction and which, at least at its two axial ends, has inner and outer pole shoes (6a, 6b) which lie radially opposite each other and are spaced apart by the air gap (5), as a result of which the magnetic field in the air gap (5) is concentrated in the radial direction in the area of the mutually facing pole shoes (6a, 6b), as a result of which at least one magnetic circuit is formed in which the magnetic field lines extend radially through the air gap (5) from the inside outwards and also through said air gap (5) from the outside inwards.
The invention further relates to an electrical linear drive of this kind in which the permanent magnet arrangement (2) is designed as a stack of frame-shaped, in particular ring-shaped magnets (2a, 2b, 2c), which are magnetized alternately radially and axially in the axial direction, such that the magnetic field is strengthened on one side of the frame or in particular ring, in particular on the radially outer side, and is weakened on the other side of the frame or in particular ring, in particular on the radially inward side, and the coil arrangement (1) is arranged coaxially with respect to the permanent magnet arrangement (2) on the side with the strengthened magnetic field....continue reading
The Emory Heart Transplant Program Posted: September 17, 2010
The Emory Center for Heart Failure Therapy and Transplantation in Atlanta, Georgia ranks among the nation's top heart transplant hospitals. We are a leader in heart transplantation and therapies to improve heart failure. Our comprehensive services include medical therapy, FDA-regulated investigational drugs and devices, cardiac catheterization, cardiac surgery, and in select patients, heart transplantation. Our Atlanta heart transplant program was established in 1985. Through integration of research, education, and patient care, Emory has established itself as the premier Southeast heart transplant program.
Emory's highly skilled and experienced multidisciplinary team includes cardiologists, heart surgeons, transplant coordinators, a social worker, mental health specialists, a pharmacist, a clinical nutritionist, a physical therapist, a chaplain, staff nurses, and a financial coordinator. Each member of the team offers a specialized service in the care of our patients.....continue reading
Mark Rodefeld, M.D
IU Surgeon Receives Heart Pump Grant September 16, 2010 Press Release
An Indiana University School of Medicine congenital heart surgeon and inventor has been awarded a $2.1 million grant from the National Institutes of Health.
Mark Rodefeld, M.D., an associate professor of surgery at the IU medical school, will use funding from the National Institutes of Health's National Heart, Lung, and Blood Institute to further develop a new type of blood pump that uses a spinning disk to pull blood from the veins and push it into the arteries of children and adults born with only one functioning heart ventricle.
Currently only 50 percent to 70 percent of infants born with univentricular circulation survive the three open-heart surgeries required in the most common treatment, the Fontan procedures. The cost of the first few months of intensive care hospitalization for an infant born with the defect often exceeds $1 million. In addition, those fortunate to survive face lifelong disability with no comprehensive therapeutic treatment.
Rodefeld said the grant will support development of the viscous impeller pump through animal testing -- one of the requisite phases prior to human trials -- Food and Drug Administration approval and commercial development.
"It's a completely new device, unlike any other that exists, so we expect the burden of proof to be high," Rodefeld said. "But we believe that in patients with univentricular Fontan circulations, young and old, this safe, simple and reliable method to augment blood flow will address their unresolved health needs."
No artificial blood pump currently exists that can provide the necessary low pressure support in the four-way flow system that is surgically constructed in patients with single ventricle heart disease to reach a final circulation known as Fontan circulation. Patients with univentricular circulations have a single effective ventricle that must pump blood to the body, and then to the lungs, in one cycle. Blood flow to the lungs has no dedicated power source, the single ventricle is overworked, and patients are susceptible to serious complications.
"Since there is no right-sided ventricular power source, blood flow back to the heart is profoundly altered, which results in a less than optimal filling of the single working ventricle," Rodefeld said. "We can augment blood flow in the right-sided circulation, reproducing the more stable, normal two-ventricle physiology."
The pump would be implanted into a four-way intersection where the body's two central veins, the superior and inferior vena cavae, join the right and left pulmonary arteries. It uses an expandable spinning disk that provides multi-directional flow capability and would be implanted with the use of a catheter, then powered by a magnetic coupling.
In September 2009, IU's Research and Technology Corp. entered into a memorandum of understanding with Rose-Hulman Institute of Technology's Rose-Hulman Ventures to develop a prototype of the pump invented by Rodefeld and Purdue University School of Mechanical Engineering Professor Steven Frankel.
The goal is to now demonstrate a working rotary disk pump in an animal model that supports univentricular circulation at the required pressure, with clinical studies in humans to hopefully follow.
Source: Indiana University
Douglas Wiley, center, his wife Patti, left, and his surgeon Dr. Craig Selzman, right
He’s taking heart-to-heart walks By kirsten Stewart The Salt Lake Tribune Published Apr 9, 2010 09:53AM Updated Sep 10, 2010 08:02PM
Six years ago Douglas Wiley was diagnosed with acromegaly, a rare disorder in which too much growth hormone causes the body and heart to enlarge. The condition strikes 117 of 1 million people a year. If left untreated, Wiley’s inflamed, weakened heart eventually would have failed.
But last month, the north Idaho man went from medical patient to medical pioneer: Wiley is the fourth person in the United States — first in the Intermountain West — to receive the Utah-made Levacor Ventricular Assist Device (VAD), a heart pump designed to keep him alive while he waits for a heart transplant.
The device, manufactured by Salt Lake City-based WorldHeart Corporation, was implanted by a University of Utah cardiologist as part of a “bridge to transplant” clinical trial under way since January. It’s the sixth successful Levacor implant worldwide and the future of treatment for people with heart failure, said Craig Selzman, the cardiothoracic surgeon who performed the procedure.
For Wiley, who was discharged from the hospital Thursday after just nine days in recovery and two weeks of rehabilitation, the technological advance means resuming an active life.....read more
VCU leads study of first US portable driver for powering the total artificial heart Posted: September 10, 2010
The VCU Pauley Heart Center is one of up to 30 centers that will investigate a portable, mechanical driver that can power patients' artificial hearts and enable them to recover outside the hospital environment, including at home and at step-down facilities.
"This is the kind of technology that changes lives," said John Duval, CEO of MCV Hospitals at the VCU Medical Center. "VCU has long been a leader in heart-assist technology, pioneering the implantation of the first Total Artificial Heart on the East Coast in 2006.
"This portable driver, if successful, will allow patients who once had to spend months, and sometimes more than a year in the hospital waiting for a donor heart, to recuperate in the comfort of their own homes," Duval said.
The VCU Medical Center received institutional review board approval in early September to participate in an Investigational Device Exemption (IDE) clinical study of the Freedom driver, the first-ever U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. The IDE clinical study is intended to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home....continue reading
The Freedom™ driver system* and the 70cc SynCardia Total Artificial Heart
Study Underway to Evaluate New Driver Designed To Provide Total Artificial Heart Patients With The Ability To Live At Home September 7, 2010
Cardiovascular disease (CVD) is the leading cause of death in the U.S. for both men and women, with an estimated 80,000,000 (one in three)1 adults having one or more types of CVD. Approximately 5,700,0001 people currently suffer from heart failure and 670,000 new cases are diagnosed annually.
Of the nearly 300,000 annual deaths in the U.S. attributed to heart failure, it is estimated that up to 100,000 people could benefit from mechanical circulatory support devices, which are surgically implanted mechanical pumps that provide blood flow to supplement or replace the blood flow normally generated by the native heart. When patients progress to end-stage biventricular failure, where both sides of the heart fail to pump enough blood to sustain the body, vital organs like the kidneys, lungs, liver and brain are starved of oxygen and nutrients, and start to shut down.
For transplant-eligible patients suffering from end-stage biventricular failure, there are two treatment options: an immediate donor heart transplant or a mechanical circulatory support device to serve as a “bridge to transplant.”
The options for implantable mechanical circulatory support devices for heart failure include left ventricular assist devices (LVAD) and the Total Artificial Heart (TAH).
Although proven to be effective, enthusiasm for utilizing the Total Artificial Heart has been limited because patients with the device are connected to a 418-pound pneumatic driver nicknamed “Big Blue,” which powers the Total Artificial Heart but does not allow hospital discharge. While these clinically stable patients continue to rehabilitate in the hospital, they are forced to live apart from their families. Being trapped in the hospital is physically, financially and emotionally draining for these otherwise stable patients.
The FDA, however, has recently granted conditional approval for the 13.5 lb Freedom™ portable driver to undergo an Investigational Device Exemption (IDE) clinical study in the United States. Through the IDE study, stable patients who meet enrollment criteria will have the option to be discharged from the hospital supported by the portable battery power of the Freedom driver.
This pneumatic driver is designed to be carried in a backpack or shoulder bag. The driver is intended to allow patients with the Total Artificial Heart to await heart transplantation at home with their families rather than in the hospital. For ease of use, the Freedom driver utilizes a ‘dark cockpit design’ meaning the patient is only alerted when something requires their attention, such as low-battery power. While data on the safety and efficacy of the Freedom driver will be available only after completion of the study, it has already received CE approval for commercial use in Europe. For complete story Click here
Device Malfunction of the CardioWest Total Artificial Heart Secondary to Catheter Entrapment of the Tricuspid Valve Posted: September 2, 2010
We report two cases at a single institution, a 52-year-old man and a 25-year-old woman, who had failures of their CardioWest total artificial hearts (TAH) from central venous lines that caused obstruction of the right ventricular inflow valves.
Each patient was noted to have decreasing TAH outputs for a few days before this catastrophic device arrest. Both patients died; one suddenly and one during a protracted period, as a result of catheter entrapment of the disc of the Medtronic Hall right ventricular inflow valve.....
Abigail Miles plays while attached to a Berlin heart. The Haughton toddler spent about six months attached to the artificial heart while awaiting a transplant. (Photos special to The (Shreveport) Times)
Pump keeps heart beating September 1, 2010
A heart pump still considered experimental gave Haughton toddler Abigail Miles a second chance at life.
Abigail is among 31 children who have used a Berlin heart ventricular assist device while awaiting a heart transplant at Arkansas Children's Hospital in Little Rock. Abigail spent about six months depending on the pump to keep blood moving through her body before receiving a new heart July 31.
Children and adults who depend on such devices risk strokes because blood tends to clot when circulating through artificial materials. Patients take blood thinners, which help reduce clotting but don't eliminate the risk.
Doctors discuss risks of using an experimental device, including the possibility of strokes, when telling families about the pros and cons of the Berlin heart.
Abigail suffered two strokes while on the machine. She recovered completely from the first and is undergoing therapy to recover from the second.
Jean’Paul Marceaux, left, and Abigail Miles cool their feet in a pool while experimental pumps do the work of their failing hearts. (Photos special to The (Shreveport) Times)
Arkansas Children's Hospital started using the Berlin heart about four years ago. Doctors send detailed information about each patient to the German company, which is studying how well the device works and ways to improve it, said Dr. Elizabeth Frazier, director of the hospital's pediatric heart transplant program.
Patients using the device undergo open heart surgery during which tubes are placed in the heart and an aorta. The tube placed in the heart sends blood into a pump placed on the person's chest. The pump sends blood into an aorta. A bulky, box-like machine on wheels powers the pump and contains controls that allow doctors to adjust the pump's rate.
Some patients require a pump only for the left chamber of the heart and some for both chambers.
"When you have two of those devices, it's like having four water hoses coming out of a child who weighs only 15 or 20 pounds," Dr. Frazier said.
She hopes for a device small enough to put in a patient's heart as the maker continues improvements.....continue reading
First-in-man implantation of mechanical heart to take place by the end of 2011 September 1, 2010
Surgeon Alain Carpentier is ready to remove a patient’s heart and replace it with a mechanical device he spent 15 years developing.
The first-in-man implantation is planned for the end of 2011 and by 2013 the procedure will be performed on 50 European patients as part of a clinical trial to win CE approval for the world’s first fully implantable artificial heart.
This year 100,000 people will be diagnosed with severe heart failure and learn they have about 12 months to live as their heart loses its ability to pump blood.
One out of 10 of these patients will receive a heart transplant, while some will be connected to a ventricular assist device (VAD) as a bridge-to-transplantation to extend their life for a couple year in the hope a suitable donor heart will be found.
Each year in Europe 50,000 people with heart failure die, having run out of options.There simply are not enough hearts to go around, and most people with severe heart failure lose the race against the clock.
“Even the great news that someone will receive a new heart is sadden by the fact that someone died for that heart to become available,” said Alain Carpentier, MD. “And we have reached the limits of what can be done with VAD, which ultimately is temporary, palliative care,” he said. “I have always been convinced that more could be done to help these patients,” he said.
In June, 2010, Dr. Carpentier, a Paris-based heart surgeon and internationally renowned inventor of heart devices, introduced a startling break-through in the fight to survive heart failure with the world’s first biocompatible, fully implantable, fully functional mechanical heart.
Carpentier’s artificial heart takes up the same space in the chest cavity as the human heart it replaces. To power the micro pumps and continually relay data on the device function, a wire runs under the skin from the artificial heart to a small port above the ear where it exits the body and descends to a shoulder harness that holds a battery pack and a data transmitter. The battery is good for five hours of operation, and patients can also bring along an adapter when visiting friends to plug into an electrical wall socket.
the world’s first biocompatible, fully implantable, fully functional mechanical heart.
“What we have created is not a crutch to assist a patient for a few years but a fully implantable human heart replacement to provide an high quality of life beyond five years,” Dr. Carpentier told European Hospital.
Patients will not be attached to bulky VAD pump wheeled around on a caddy, he said, indicating a poster promoting his new heart that shows a patient riding a bicycle.
Nor will the device require an complex regime of medications to fight rejection of the transplanted heart, he said, as the 40 components of the Carpentier heart use only materials already approved for biocompatibility.
In July Carmat SAS, the company created to transfer Carpentier’s technology from the laboratory to the commercial market, launched a public stock offering that exceeded analysts’ expectations, raising more than €18 million. Carmat said it plans to use the fresh capital to finalize pre-clinical testing of the device and finance the manufacturing of up to 40 hearts.
The first-in-man implantation is planned for the end of 2011, and by 2013 more than 50 patients in France, Germany and Italy will receive an artificial heart as part of the pre-clinical testing program that Carmat says it hopes will lead to a CE mark by the end of that year......read more
Hospital wants state to pay for transplants August 19, 2010
ONE of Sydney's biggest hospitals is more than $5 million in debt because the state government has refused to fund its world-renowned heart transplant program - even though the country's three other transplant units are all government funded.
Cardiac surgeons at St Vincent's Hospital, the home of Australia's first heart transplant in 1968, have called on the Health Department for urgent help, saying they are being forced to rely on public donations for life-saving surgery.
In the past few years the cost of running the heart-lung transplant program has soared as technology has improved.
Mechanical pumps, also called left ventricular assist devices, are now given to about a third of all patients waiting for a heart transplant. They cost about $100,000 each and are not reusable.
St Vincent's also spends about $1.8 million a year putting some patients on ventilators to keep their hearts and lungs working while they wait for a transplant.
About 16 people a year are given the pumps at St Vincent's, at a cost of $1.6 million, paid for using money bequeathed or donated to the hospital....continue reading
St Vincent s hospital heart surgeon Dr Paul Jansz talks with artifical heart surgery patient Angelo Tigano, 50, the first recipient of the total artificial heart in the Southern Hemisphere. Photo: Kate Geraghty
Man gets Australia's first artificial heart implant August 16, 2010
Sydney's St Vincent's Hospital says it has recently performed the Southern Hemisphere's first total artificial heart implant.
Angelo Tigano, 50, from Fairfield in Sydney's west, was suffering from total heart failure after having idiopathic cardiomyopathy for more than 10 years.
He was selected to have the implant because without it he may have had less than two weeks to live.
Mr Tigano underwent five hours of surgery, during which his own heart was removed and replaced with a mechanical device.
It mimics the function of both the left and right heart ventricles, which are responsible for pumping blood.
The device is said to provide up to 9.5 litres of bloodflow throughout the body per minute.
The hospital says the 50-year-old should now be able to live a relatively normal life until a heart transplant becomes available....continue reading
Thoratec's HeartMate II
Small Assist Device Used in Emergency Case as Twin, Heart Booster Pumps for First Time in U.S.
CHICAGO, Aug. 10 /PRNewswire-USNewswire/ -- The Bluhm Cardiovascular Institute of Northwestern Memorial Hospital recently implanted a patient with two of the smallest experimental ventricular assist devices (VADs) currently available for study in humans. VADs are designed to assist either the right (RVAD) or left (LVAD) ventricle, or both (BiVAD) at once. This is the first time that two Heartware™ VADs have been implanted in the left and right ventricles anywhere in North America—a "game changer" in the realm of heart assist devices according to Patrick M. McCarthy, MD, chief of the hospital's division of cardiac surgery and director of the hospital's Bluhm Cardiovascular Institute....read more
ASSIST PUMP Khristine Orlanes, a nurse practitioner, found the batteries for Mr. Volpe.
A Heart Pump Ticks Down, and a Stranger Steps In to Help August 9, 2010
Christian Volpe was shopping with his wife when an alarm started beeping to warn that only 15 minutes of battery power were left on the implanted heart pump that was keeping him alive.
Mr. Volpe, 67, a slight, gray-haired man, looked in his car for the bag he always keeps nearby with spare batteries. But, no bag. In his mind?s eye he saw exactly where he had left it, to make sure he would not forget it, on a chair near the door back home ? an hour and a half away. He thought of the clever little hand pump he had been given to keep his mechanical heart going in an emergency. It, too, was in the missing bag. Standing in the parking lot, he could hear one thing. Beep. Beep. Beep. ?I have to admit, I panicked,? he said.
Mr. Volpe is one of thousands of Americans who have had these pumps, called left ventricular assist devices, surgically implanted to help their failing hearts. Former Vice President Dick Cheney is another. Sometimes the pumps are used to keep people alive until a transplant becomes available, but in other cases they are meant to remain as long as the patient lives.
Mr. Volpe, a retired subway conductor who had had two heart attacks and two bypass operations, had an assist pump implanted in October 2009 by Dr. Yoshifumi Naka at NewYork-Presbyterian/Columbia hospital.
The pump is placed near the patient’s own heart. A power line emerges about waist level and connects to a controller, a mini-computer which plugs into a pair of one-and-a-half-pound, 12-volt batteries. Patients wear a black mesh vest over their clothing that holds the controller and batteries. The pump Mr. Volpe had, a HeartMate XVE, made by Thoratec, could run for about four hours on two batteries. The pumps cost $70,000 to $80,000, usually covered by insurance.
That day in the parking lot in December, in Fishkill, in upstate New York, Mr. Volpe was too far from Columbia to get there in time. But his wife phoned its heart-pump clinic, and nurse practitioners told her to call 911 for an ambulance to the nearest hospital.
Mr. Volpe knew that if the pump stopped, he was not likely to die immediately; his own heart, though weak, would probably keep him alive. But he was still in real danger, because clots would form in the mechanical heart if it quit, and cause a stroke if they escaped into his bloodstream....continue reading
DOJ Likely To Intervene In St. Jude Heart Device Kickback Lawsuit August 9, 2010 by Kaiser Health News
The U.S. Department of Justice may intervene in a lawsuit against heart-device maker St. Jude Medical Inc. after allegations the company used medical studies to "pay kickbacks and boost product usage," The Wall Street Journal reports.
"The U.S. Attorney's office in Boston launched an industry-wide probe nearly five years ago into whether makers of pacemakers and defibrillators were making improper payments to doctors. The government had filed a notice in federal court in December saying its investigation wasn't complete, and that it wasn't intervening in the former St. Jude worker's lawsuit at that time.
In a motion filed in federal court Thursday, however, the government said it has since interviewed more witnesses and reviewed more documents, completed its probe and now 'has good cause to intervene.'" The lawsuit is being brought by a former worker who accuses St. Jude of paying kickbacks to doctors for prescribing certain products the device-maker made (Kamp and Loftus, 8/9).
Cheney Gets Heart Pump Implant July 15, 2010 5;19 AM
Former Vice President Dick Cheney is recovering after receiving a left ventricular assist device that helps the heart pump blood. Bill Plante reports;
In this July 8, 2001 file photo released by The White House to The Associated Press, Vice President Dick Cheney smiles while fly-fishing on the Snake River with his family in his home state of Wyoming.
Cheney Released from Hospital August 9 2010
Former Vice President Dick Cheney was released Monday from the hospital, about a month after doctors installed a new pump in his chest to assist his damaged heart. A spokesman said in a brief statement that the vice president “was released from Fairfax hospital and returned home this morning.”
Cheney had his first heart attack at 37-years-old and his most recent one in February. He entered the hospital in late June complaining of discomfort, and later disclosed that he was “entering a new phase of the disease when I began to experience increasing congestive heart failure.”
That led to the decision to implant a left ventricular assist device, or LVAD, in his chest in July. While the treatment is relatively new, one of Cheney’s doctors held out hope last week that the former vice president will be able to return to an active life...continue reading
With less than an hour to live, musician finds timely help August 5, 2010
Desperate race for battery for heart pump ends on a high note
John Merrill glanced at the battery light on his ventricular heart pump Wednesday and realized he was running out of time.
Exactly how long, he didn’t know. The warning light indicated less than an hour before the pump — and his heart — would come to a standstill.
The 79-year-old El Cajon clarinetist was preparing to perform in a concert at Balboa Park that evening and had unfortunately forgotten his replacement batteries at home.
He survived to tell his tale, thanks to the quick thinking and swift actions of hospital staff and paramedics, Merrill said Thursday.
He is one of just 60 people in the county and 4,000 worldwide with a HeartMate II Left Ventricular Assist Device, or LVAD, that maintains the pumping ability of a heart that can’t work on its own.
Former Vice President Dick Cheney had the lightweight device implanted in his chest last month. The pump relies on an external battery that needs to be changed every few hours....read more
The SynCardia Total Artificial Heart
Artificial heart goes portable August 5, 2010
For a sick patient in need of a heart transplant, the agonizing wait for a donor meant living at the hospital, tethered to a washing machine-sized device that powered an artificial heart. But this summer, an artificial heart company announced the development of a portable, backpack-sized driver that allowed three patients to wait for transplants from home.
I spoke recently with Steve Langford of SynCardia Systems, manufacturer of the temporary Total Artificial Heart and the new, portable Freedom Driver, about how patients whose hearts are no longer pumping enough blood can have their ventricles replaced by a device powered by a driver carried over the shoulder.
The SynCardia Total Artificial Heart is an air-powered device. It requires attachment to an external controller, which actually inflates internal membranes inside the [artificial] heart.
When the internal membranes are inflated, it pushes the blood out of the [artificial ventricles]. We use valves inside of the [artificial] heart to control the direction of the blood flow. We currently have a 13.5-pound Freedom drive system which enables patients [who are in stable condition and meet the criteria] to be enrolled in an FDA study. (The study is designed to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home.)
Patients, when they have the artificial heart, become very well, very quickly. When they are attached to this 13.5-pound driver, it’s like having a small backpack or a book bag that they can carry with them. It enables them to have complete mobility and a virtually-normal lifestyle....continue reading
Clanton man survives with help of heart pump August 3, 2010
Bud Esposite of Clanton has to carry around an extra 27 and a half pounds every day. Seven and a half pounds account for his heart pump and the two battery packs he must wear over his shoulders; the other 20 pounds are from the four extra sets of batteries he carries in his bag. He also cannot do certain routine activities -- such as mowing the lawn, swimming, or walking through a metal detector -- because of the heart pump's sensitivity.
Then there's the everyday curiosity of passers by. "I get a lot of weird looks," Esposite said. "I just look at them and say, 'If you only knew.'" That's just a taste of life with a heart pump -- the bulky but lifesaving device that helps Esposite keep his independence, at least to some degree.
Esposite, now 53, has congestive heart failure, the symptoms of which started showing up in 2001. At age 44 he began to experience dizziness, blackouts, weakness and difficulty breathing. He got a pacemaker and defibrillator in 2002 and was placed on the heart pump in August 2006.
The pump he has now is the second one he has used. Wearing one requires a lengthy surgical procedure because the actual pump, located inside the body, must be connected to a controller worn along the waist. Esposite said the surgery took about 12 hours.
"Getting the second pump was a little worse than the first because it took longer to get used to," he said.
The pump takes blood from the left side of the heart and pumps it back through, regulating the flow of blood throughout the body while keeping swelling in check. It's basically his lifeline. "Along with medication -- lots of medications," Esposite said.
His daily routine also includes blood pressure checks, temperature checks, and regular changes of the sterilized bandage that covers the wire's exit point in the abdomen. Batteries in the device must be changed and recharged every three hours. A series of lights on the controller indicates how much charge is left in the batteries.
At night, he hooks up to a power-based unit that keeps the batteries charged while he sleeps. Should the power fail, he has a battery backup. The batteries are also very sensitive, especially to temperature. For this reason, Esposite must be careful outdoors....click on .zip file for complete story
Scientists develop a wireless heart pump Auckland, Newzealand, September 16
In an interesting breakthrough that could save thousands suffering from cardiac problems, scientists at Auckland University have developed a technology to power a wireless heart pump.
Heart pumps are used to keep patients alive before heart surgeryand require a large amount of power. The method currently used requires a wire cable to go through the stomach and chest.
This current technologyis fraught with dangers like causing infections in about 40 percent of patients and can sometimes be fatal. In addition, the wires are given to breaking and inhibit a patient's activities.
"We would very much like for it to be the preferred choice for patients to be able to choose this type of pump over a heart transplant,” said David Budgett of the University of Auckland.
The new wireless pump is developed in collaboration between scientists from Auckland University's Bioengineering Institute, Department of Electrical and Computer Engineering and Department of Physiology. It will be marketed by a new company, TETCor.
Features of the wireless heart pump
According to the scientists, the un-intrusive system uses magnetic fields instead of wire cables to pass power across a patient’s skin. This permits the pump to be continuously powered during a person’s lifetime.
Giving details about the pump, Dr Simon Maples CEO of TETCor stated, “This new wireless heart pump weighs only 92 grams and measures just seven centimeters by three centimeters.
He further added, "It uses a coil outside a person’s body to generate a magnetic field. A second coil placed inside a person’s body, near the collar bone, picks up the signal from this field and creates power for the pump.”
Dr Maples said the earlier attempts to develop wireless pumps produced too much heat that ended up "cooking a person from the inside". However, in the new technology, the heating problem is removed to deliver only the right amount of power....continue reading
Leonor Ortiz Childers, 46, plays with her children
New HeartMate II pump is latest bridge to life February 16, 2010
When Leonor Childers' heart quit, it wasn't without reason. Childers, 46, a mother of four, was pregnant with her second set of twins when she was diagnosed with breast cancer. What followed would tax any heart, she says: "A mastectomy, chemotherapy, an emergency C-section, more chemotherapy and six weeks of radiation."
Two weeks later, Childers suffered cardiac arrest. "It's hard to pinpoint what caused it," she says. "My body just started shutting down, saying enough is enough. My liver blew out, my kidneys blew out. It was a life-or-death situation." Fortunately for Childers, of Durham, N.C., her doctors had on hand the technology she needed to tip the scales back toward life: a heart pump called the HeartMate II, which won government approval Jan. 20 for patients who can't tolerate a transplant.
The HeartMate II is the second in a series of pumps designed to sustain heart-failure patients until a donor heart becomes available. A souped-up successor to the HeartMate I, which offered patients only a short-lived reprieve, the HeartMate II has revived a dream that a mechanical device may serve effectively as a "destination" therapy for patients who can't find a donor heart or may not survive a transplant.
Childers won't be eligible for a transplant until she has been cancer-free for five years, in 2012, because the anti-rejection drugs may suppress her immune system and allow the cancer to return. Without her HeartMate, she would have died. "It has given me 453 days that I wouldn't have had with my family," she says. "Days mean a lot to me. Hours mean a lot to me."....read more
First Heart Patients Implanted With Next-Generation Mechanical Heart Pump NEW YORK (May 29, 2009)
NewYork-Presbyterian/Columbia Is Currently One of Only Three Centers in the U.S. to Offer the DuraHeart System for Patients With Severe Left-Ventricular Heart Failure
Three patients at NewYork-Presbyterian Hospital/Columbia University Medical Center were among the first in the United States to be implanted with a next-generation artificial heart pump called the DuraHeart™ Left-Ventricular Assist System.
The surgeries took place earlier this year. NewYork-Presbyterian/Columbia is one of only three centers in the U.S. currently enrolling patients in a clinical trial studying the device.
The DuraHeart is designed to sustain patients with severe left-ventricular heart failure while they wait for a heart transplant. Without intervention, they are at risk of death.
The surgeries were led by Dr. Yoshifumi Naka, director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of surgery at Columbia University College of Physicians and Surgeons. He elected to implant the device without stopping the heart and putting the patient on a heart-lung machine. This "off pump" approach reduces risk for bleeding and stroke associated with putting a patient on bypass....continue reading
Virtual heart pumps up the realism May 2009 by New Scientist Posted: August 19, 2010
This super-realistic computer model makes it possible to explore the heart's anatomy in ways not possible in real patients.
Created by a team of doctors from the Heart Hospital in London and computer animators from post-production company Glassworks, the beating heart can be manipulated via a computer mouse or keyboard (see video).
The viewer can rotate the virtual organ around any axis and view it from both inside and outside. The heart can also be set to beat normally, or mirror the effects of various conditions and diseases.
As well as a teaching aid for medical students, the 3D model should provide a useful reference tool for heart specialists, say its creators.
VAD Maker Thoratec Acquires HeartWare for $282 Million February 16, 2009
Thoratec Corp. and HeartWare International last week entered into a definitive merger agreement under which Thoratec will acquire HeartWare for a about $282 million, and the combined company will offer a broad portfolio of approved blood pumping devices for the treatment of heart failure.
The companies said approximately 50 percent of the purchase price will be paid in cash and about 50 percent will be paid in shares of Thoratec common stock. Based on a Thoratec common stock price of $26.25 per share, this reflects a current price of $0.86 for each HeartWare Chess Depositary Interest (CDI), or $1.32-Austrialian based on the current U.S./AUS exchange rate of 1.5265.
"This transaction is a positive development for heart failure patients and the clinicians who treat them by combining Thoratec’s portfolio of commercially approved devices with HeartWare’s innovative technologies,” said Gary F. Burbach, president and chief executive officer of Thoratec. “The use of mechanical circulatory support for the treatment of heart failure is gaining increasing adoption as a result of the positive patient outcomes and clinician enthusiasm realized with the HeartMate II. We believe that combining the strengths of the two companies will enable us to build upon each of our strong technology and product platforms, giving more and better options for a large and significantly underserved heart failure patient population.
HeartWare recently received the CE Mark for the HeartWare Ventricular Assist System and said it is experiencing strong initial progress in its U.S. BTT trial. The company is also working on its MVAD, a next generation miniaturized axial flow LVAD (left ventricular assist device).
Thoratec’s product line includes several commercially approved cardiac assist devices including the HeartMate II LVAS, which received U.S. approval for bridge-to-transplantation (BTT) in April 2008 and is currently in clinical trials in the U.S. for destination therapy (DT) or the long-term support of heart failure patients not eligible for transplantation.
Upon the close of the transaction, HeartWare's operations will be integrated into Thoratec's Cardiovascular Division. Further details regarding the nature and timing of the integration will be provided in the future...continue reading
New Continuous Flow Heart Pump Under Development October 28, 2008
Thanks to $2.8M NIH grant, University of Houston mechanical engineers are embarking on a project to develop a novel continuous heart pump. The project may develop a considerably smaller device suitable for implantation into younger patients.
From U of Houston press release:
As part of a biomedical research team working to create a pulseless total artificial heart (TAH), Matthew Franchek and Ralph Metcalfe, both mechanical engineering professors in the Cullen College of Engineering at UH, are focusing on developing a control system that emulates how the natural heart responds to physiological conditions within the body. The TAH is designed to perform the function of both the right and left ventricles, and these advancements in technology are meant to enable it to respond to the body’s changing need for blood.
The professors say the complexity of existing devices that just mimic the pulsating pump action of the natural heart not only makes their size nearly impossible for use in smaller adults and children, but also causes reliability concerns, such as failure due to mechanical fatigue. The proposed TAH replaces the pulsatile feature with two pulseless continuous flow pumps, each about the size of a C battery. The pumps also are unique in that their cardiac output automatically adjusts to physiological needs. To ensure proper integration of the TAH on a patient-to-patient basis, the UH team will be adding onboard intelligence to the TAH using automatic controls.
One pump would be dedicated to the pulmonary loop, carrying oxygen-depleted blood away from the heart to the lungs and returning oxygenated blood back to the heart. The other pump would drive the systemic loop, carrying oxygenated blood away from the heart to the body and returning deoxygenated blood back to the heart.
Franchek’s and Metcalfe’s roles in the project will focus on the mathematical modeling of the cardiovascular system to create a feedback controller that will seamlessly integrate the device with a recipient’s body. The overarching goal is to create a robust continuous-flow ventricular assist device that is smaller and more reliable than the current pulsating pumps that mimic the natural heart. The mathematical models of the cardiovascular system also will be evaluated as a possible means to health prognostics and diagnostics. In addition, information from the controllers will be used to assess current conditions of the blood, including viscosity, which is critical to maintaining patient health.
Matthew Franchek and Ralph Metcalfe, both mechanical engineering professors in the Cullen College of Engineering at UH, are part of a biomedical research team working to create a pulseless total artificial heart
Pictured is a device similar to the less-costly, smaller pulseless artificial heart to be created that will perform the function of both the right and left ventricles of the heart
Impella 2.5 Cardiac Assist Device Now Available to Doctors and Patients in the U.S. June 2, 2008
The U.S. Food and Drug Administration (FDA) just cleared the Impella 2.5 Cardiac Assist Device for immediate use. Designed for cardiac arrest and heart attack patients, it pumps up to 2.5 liters of blood per minute, and supports the heart in situations when it cannot function on its own. Each year over a million people in the U.S. have a heart attack, according to the National Institutes of Health. Of that statistic, half of them die and many are left with permanent heart damage.
As the world's smallest Ventricular Assist Device (VAD), this technology provides patients with immediate, sustained coronary perfusion when their heart is unable to do so. The Impella 2.5 is inserted percutaneously in the catheterization laboratory (cath lab) through the femoral artery into the left ventricle. It is the only device designed to actively unload blood from the ventricle and is approved for short term use for up to six hours.
Today's clearance allows Abiomed to begin selling the device for use to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States...for more information Click here
Transplant surgeon H. Todd Massey, M.D and Robert Jarvik, M.D., inventor of the Jarvik 2000
Jarvik Artificial Heart Pump Helps First Patient in Upstate New York October 18, 2007
A Rochester-area resident was the first recipient to receive a Jarvik 2000 artificial heart pump at the University of Rochester Medical Center. The ventricular assist device will help the heart failure patient’s native heart pump blood more effectively throughout his body in an effort to keep him as healthy as possible as he waits for a cardiac transplant.
The device was implanted during a six-hour operation on Sept. 24, performed by transplant surgeon H. Todd Massey, M.D., surgical director of the University of Rochester Medical Center’s Program in Heart Failure and Transplantation and director of the Artificial Heart Program. Also present in the operating room was Robert Jarvik, M.D., inventor of the Jarvik 2000 and other ventricular assist devices. Jarvik may be best known as developer of the Jarvik-7, the first total artificial heart, which was implanted in patient Barney Clark in 1982 at the University of Utah....read more
FDA Approves Implanted Heart Pumps That Lengthen and Improve Lives of Terminally Ill Heart Failure Patients NEW YORK (Nov 7, 2002)
Landmark Study Led By Columbia University Medical Center Researchers Leads To FDA Approval
Almost one year after Columbia University Medical Center researchers completed a three-year landmark clinical trial that found implanted heart pumps lengthen and improve the lives of terminally ill heart failure patients, the Food and Drug Administration has approved the pump for use by patients who are ineligible for transplant.
The pump, known as the HeartMate VE, is manufactured by the Pleasanton, Calif.-based Thoratec Corp. Previously the FDA would allow the use of implanted pump devices only as a bridge to transplantation and after certain types of cardiac surgery. The pump will be implanted in patients at Columbia University Medical Center....continue reading
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