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Kidney & Dialysis News Archives: 2012-2013
Green Kidney Operation
Cancer breakthrough as luminous liquid lets surgeons locate and remove tumours
December 7, 2013
A new procedure that combines luminous green dye, robotics and 3D vision is enabling surgeons to remove kidney tumours accurately – meaning patients no longer need lose the entire organ.
Such tumours can be extremely difficult to diagnose and locate, but in the increasingly high-tech battle against cancer, the dye illuminates healthy tissue while robotic arms fitted with a high-resolution camera cut away cancerous areas.
The procedure was first performed in the UK at St George’s Hospital in South London during the summer.
‘This is a significant advance,’ says consultant urologist Steve Bromage. ‘It’s a new cost-effective technique that helps surgeons preserve as much kidney function as possible while still removing all the malignant tissue.’
But the extensions of many tumours are difficult to spot with the naked eye, so surgeons currently rely on scans, and blood and tissue tests, to guide them. But these can still fail to spot all of the cancer, which makes the new dye technique so vital.
The dye has previously been used to help identify eye and liver cancers.
‘It’s a great tool and has brought new-found clarity to the procedure,’ says Professor Chris Anderson, a urologist at St George’s Hospital, who launched the new technology – known as Firefly – in the UK. He used a ‘da Vinci’ robot for the operation, which comprises miniature instruments that are inserted through small incisions and operated remotely by a surgeon using a magnified view.......read more
Medical device startups hit by decline of venture capital investment
December 1, 2013
Peter DeComo raised $20 million from investors for Renal Solutions Inc. in 2002, when the Pittsburgh medical device company had only a working prototype for an artificial kidney and no money.
During the next five years, he brought in $20 million more in capital before selling Renal Solutions Inc. to a German outfit in 2007 for nearly $200 million.
"That company couldn't even get funded today," lamented DeComo, the CEO of South Side -based ALung Technologies Inc. , because venture capital investors have pulled back from startup companies in his industry.
With that important funding source drying up, DeComo worries many promising young companies in the Pittsburgh region may never get off the ground. "What it means, I believe, is that innovation will be stifled and good companies won't survive," he said.
Across the country, the amount of money invested in startup companies is rebounding after taking a nosedive during the recession of 2008 and 2009. But the portion of venture capital going to medical devices has continued to decline since hitting a high in 2007......read more
The artificial kidney developed by the consortium. Image courtesy of CEA-Leti.
CEA-Leti and Nine Partners to Develop an Artificial Kidney
June 25, 2013
CEA-Leti and nine partners in the NEPHRON+ project are developing an artificial kidney that would provide a major improvement in treating patients with chronic kidney failure.
The goal is a next-generation, integrated system that allows real-time, continuous, multiparametric monitoring of the patient and the device via sensors developed by Leti and its partners. The continuous data collection will allow early detection of device anomalies and a trend analysis on the health status of the patient, which would be used to improve treatment.
The renal-care system, contained in a rectangular holder that is worn on the patient’s side, offers improved blood filtering and allows patients to avoid required periodic dialysis treatments. Leti’s contribution also will include the design, development and the integration of the electrochemical platform in the artificial kidney.
Leti focused on miniaturizing the sensors to embed them in the device, as well as improving the electronic board that converts the sensor electrical signals in a ready-to-use concentration. To achieve this, researchers developed an electrochemical platform including five biocompatible ionic selective electrodes (ISE) able to monitor ion concentrations, as well as a reference electrode, a temperature sensor and an EPROM to store parameters (calibration curves).....read more
Medtronic takes '1st step' toward U.S. sale of artificial pancreas
June 22, 2013
Type 1 diabetics, who run the risk of dangerously low blood sugar, may be a step closer to getting help from a crude artificial pancreas device that can read blood sugar levels and automatically turn off the flow of insulin after a clinical trial showed the device is safe.
The long-awaited results of the clinical trial may pave the way for U.S. approval of the device, made by Medtronic, which already sells insulin pumps with an automatic shutoff feature in 50 countries outside the United States. The feature is meant to guard against delivering insulin to diabetics their blood sugar is already too low.
U.S. regulators have refused to allow insulin pumps with an automatic shutoff feature on the U.S. market without a large, carefully controlled clinical trial proving they are safe.
The latest study, known as ASPIRE, which tested the system in 247 people with diabetes in their homes, offered the proof.
It showed the device reduced the amount of time and the duration that a diabetic's blood sugar fell below a certain threshold - a measure known as area under the curve - by 37.5 percent. The device reduced the overall number of low blood sugar episodes by 31.8 percent compared to diabetics using an insulin pump without the shutoff feature.
The findings were published online on Saturday in the New England Journal of Medicine and presented at the American Diabetes Association meeting in Chicago.....read more
Bioengineered kidney created at the Massachusetts General Hospital. Click on Image to see Video
Scientists bioengineer kidneys that work in rats
April 15, 2013
Rats have received working kidneys that were grown in a laboratory, possibly opening the door for scientists to be able to grow genetically-customized organs for human patients.
"This study reports important milestones toward engineering replacement kidney grafts [and] shows the potential for this strategy," urologist Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest School of Medicine in Winston-Salem, North Carolina, said to Nature.com. He was not involved in the study.
To create the kidneys, scientists at Massachusetts General Hospital in Boston began by using cadaver kidneys. The cells inside the organs were removed, leaving behind a collagen structure of connected tissues. Immature kidney cells from newborn rats and human umbilical-vein cells were injected into the blank structure. The kidney cells would eventually develop into tissues, and the umbilical-vein cells into cells that lined blood vessels.
The engineered kidneys were able to produce urine and remove creatinine, which is a blood component which is normally removed by the kidneys. However, they were not able to function as well as a normal kidney. They only removed 23 percent as much creatinine in the laboratory, and only 5 to 10 percent when they were implanted.
Study author Dr. Harald C. Ott, a surgeon and researcher at the Mass. General Center for Regenerative Medicine, pointed out to the Los Angeles Times, however, that he wanted to show that it was possible to create these kidneys, and even these minor milestones were important.
Theoretically, because scientists would be able to fit the kidneys genetically to the patient, this could minimize the risk for organ rejection. This would also allow scientists to use any organ that was donated, instead of waiting for a genetic match for the specific patient. In the future, they may even be able to restructure the patient's kidney from their own damaged organ......read more
An Implantable Artificial Kidney: Interview with UCSF’s Dr. Shuvo Roy
November 27, 2012
Though perhaps hyperbolic, the kidney is often taken for granted especially compared to organs such as the brain and the heart. The body knows better and, at rest, actually sends about a quarter of cardiac output to the kidneys (rivaling that provided to the brain and greatly surpassing those to other vital organs, the heart itself included).
The kidney may be relatively ignored because most of us have two of them and thus live-donor transplants are more readily available than they are for other organs. What is often forgotten, however, is that demand still greatly surpasses supply, which is why we still have thousands of people in end stage renal disease (ESRD) who spend their lives on dialysis.
Within a decade or two, this may no longer be the case. Researchers at UCSF have made strides towards developing an artificial, implantable kidney – essentially a self-contained dialysis unit. Shiv Gaglani from Medgadget had the opportunity to speak with team leader, Dr. Shuvo Roy, about his team’s work........click here to read interview
UCSF to create first implantable device for patients with kidney failure
October 3, 2012
A $750,000 gift from the John and Marcia Goldman Foundation is spurring a UCSF-led effort to create the first implantable artificial kidney for patients with kidney failure.
The new funds, which augment a $2.25 million grant for the project from the National Institutes of Health this summer, will enable the team of bioengineers, physicians and scientists to conduct the critical research needed to bring the proposed device to clinical trials by 2017.
Working with the project's medical director, William Fissell, MD, at Vanderbilt University, UCSF's Shuvo Roy, PhD is coordinating researchers in nine institutions nationwide to create an implantable device that aims to mimic the filtration functions of a kidney, as well as its ability to maintain water and salt balances, produce Vitamin D, and regulate blood pressure and pH......read more
New Market Research Report "Global Artificial Organs Industry"
August 13, 2012
This report analyzes the worldwide markets for Artificial Organs in US$ Million by the following Product Segments: Artificial Heart, Artificial Kidneys, Artificial Liver, Artificial Pancreas, and Artificial Lungs. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets.
The report profiles 54 companies including many key and niche players such as Abbott Diabetes Care, Abiomed Inc., Asahi Kasei Kuraray Medical Co., Ltd., Baxter International, Inc., F. Hoffmann-La Roche Ltd., Fresenius Medical Care AG & Co. KGaA, Fresenius Medical Care North America, Inc., Fresenius Kawasumi, Gambro AB, HeartWare International, Inc., HepaLife Technologies, Inc., Alliqua, Inc., Jarvik Heart, Inc., MC3, Inc., Medtronic, Inc., MicroMed Cardiovascular, Inc., Nikkiso Co., Ltd., Nipro Corporation, SynCardia Systems, Inc., Terumo Corporation, Thoratec Corporation, Toray Medical Co., Ltd., Vital Therapies, Inc., and WorldHeart Corp.
Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.
The biotech project is in the works that could soon change the lives of thousands of kidney patients.
The FDA is now helping to fast-track an artificial kidney device being developed at UCSF.
ABC7 News Health and Science Reporter Carolyn Johnson has the details....
More Progress Made on Artificial Pancreas for Diabetes Patients
June 10, 2012
Several groups refining systems that would monitor and adjust blood sugar levels.
Progress continues to be made on the development of an artificial pancreas, a device that would ease the burden of living with type 1 diabetes.
Several artificial pancreas research groups presented their latest findings Saturday at the American Diabetes Association annual meeting in Philadelphia, and the hope is that the makers of one or more of the devices will be seeking regulatory approval within the next five years.
Type 1 diabetes is an autoimmune disease in which the body's immune system turns against healthy cells. In type 1 diabetes, the immune system attacks beta cells in the pancreas, effectively destroying the body's ability to produce the hormone insulin. Insulin helps metabolize carbohydrates from food and fuels the body's cells.
Type 1 diabetes can be managed with insulin injections or a pump that delivers insulin via a tiny catheter inserted under the skin every few days. The problem with both insulin-delivery techniques is that people have to estimate how much insulin they'll need based on the foods they eat and how much activity they will be doing. Too much insulin can result in low blood sugar levels (hypoglycemia), which, in turn, can cause a person to pass out. Low blood sugar levels can even lead to death. Too little insulin leads to high blood sugar levels (hyperglycemia), which over time can cause serious complications, such as heart disease and kidney and eye problems.
An artificial pancreas, which sometimes is referred to as a closed-loop system because it doesn't require user input, could potentially solve those problems by taking over the decision-making process and applying sophisticated computer algorithms to decide how much insulin is needed at any given moment.
But developing such a device isn't as easy as it sounds......read more
Beverly Hills Doctor On Fast Track To FDA Approval For WAK
May 13, 2012
Dr. Victor Gura began creating the initial models for his Wearable Artificial Kidney (WAK), in an exam room in his Beverly Hills medical offices 10 years ago. He is a kidney specialist and an Associate Clinical Professor at UCLA, specifically working with patients on dialysis. His goal was to create a wearable dialysis machine, so patients would not have to be tied down for many hours to a big machine, and would get more dialysis time but feel much better as they could walk around with a miniaturized battery operated machine worn as a belt.
Earlier this month, Gura’s Wearable Artificial Kidney (WAK) was one of three projects accepted into the Federal Drug Administration End Stage Renal Disease (ESRD) Innovation Challenge. The ESRD Challenge is an accelerated program to assist new projects in dialysis treatments, in getting fast approval from the FDA to make it available to the public in the US.
The WAK is the first miniaturized dialysis machine of its kind in the world. It is battery operated and uses very little water as compared to the currently used machines. Gura said that in the past some Nephrology specialists have been skeptical of the WAK, but that now his concept has gained world wide acceptance.
Gura said the WAK has been tested in the lab, on pigs, and in two successful human trials in Italy and the United Kindgdom. Now, it will undergo trials across the country, in different facilities including the University of Washington, Downstate New York, UCSD and Vanderbilt, for different periods of time.
He said he is hoping the trials will be completed in less than two years.
Global Surgical Devices Market Growth Driven by Improving Standards of Living and Longer Life Expectancies, Research Shows
April 17, 2012. Source PR Newswire
Global Information Inc. is pleased to announce three significant new reports showing strong growth in the medical devices markets, driven by improving standards of living and longer life expectancies.
Renal Dialysis Equipment Market to 2017:
The growing prevalence of diabetes, hypertension and an increasingly large elderly population are driving rapid growth in the number of End Stage Renal Disease (ESRD) patients the market globally, according to GBI Research's new report, "Renal Dialysis Equipment Market to 2017- Lower Costs and Similar Efficacy Rates as Hemodialysis to Increase Adoption Rates of Peritoneal Dialysis". Factors such as the improving standards of living in developing economies and longer life expectancies of dialysis patients, due to improved access to healthcare services are also expected to boost the market.
As the market for Artificial Organs heats up, Global Industry Analysts, Inc's new Artificial Organs market forecast and research report analyzes the worldwide markets for Artificial Organs in US $ Million. This 289 page report pulls together detailed analysis for multiple market segments, including Artificial Hearts, Artificial Kidneys, Artificial Livers, Artificial Pancreases, and Artificial Lungs. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets.
FDA announces plans to pilot end-stage kidney disease technology in new program
April 9, 2012
The Food and Drug Administration announced plans to pilot its second version of the Innovation Pathway, called "Innovation Pathway 2.0." meant to put new technology for end-stage renal disease (ESRD) in the hands of patients who need it.
The three products that have been chosen to participate in the FDA’s ‘Innovation Pathway 2.0’ program are:
The three devices are all novel technologies that treat end-stage renal disease, or progressive kidney failure, and are developed by start-up companies or academic institutions.
The move comes as device makers push the FDA to promote innovation and speed up the review of devices, while advocacy groups contend the agency is doing too little to protect consumers.
There were 32 product applications submitted, in total. The majority of the applications came from small, start-up business or academic institutions, according to the FDA.
Innovation Pathway, first announced in 2011, is an evolving system designed to help safe, breakthrough medical products reach patients in a timely manner.
Innovation Pathway 2.0, launched on April 9, 2012, offers new and modified tools and methods to deepen collaboration between the FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory process more efficient and timely.
FDA Selects CreatiVasc For New Innovation Pathway Program
April 9, 2012
Greenville-based CreatiVasc Medical has been selected as one of the first three companies for the FDA's new Innovation Pathway program that uses collaboration with innovators to speed important medical devices to market while safeguarding patient safety.
The company has developed an innovative device for dialysis patients, called the Hemoaccess Valve System®, which has the potential to significantly reduce the complications, costly interventional surgery and suffering associated with End Stage Renal Disease patients on dialysis.
The valve system device is now in Phase I human clinical trials. Unlike current dialysis-access graft devices which are prone to clotting and early failure, the CreatiVasc technology is implanted when a patient's access graft is created and allows blood flow to be turned on through the patient's graft only when it is needed for dialysis, then turned off afterward. CreatiVasc and FDA will begin their collaboration in early May.
Company officials said the device could be on the market and available for patients within 24 months.
End Stage Renal Disease, the focus of the first Innovation Pathway, affects more than 571,000 Americans and is considered one of the most costly chronic diseases. Kidney failure and associated dialysis cost the U.S. healthcare system more than $46 billion annually.....read more
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