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FDA fast-tracks approval process of 3 kidney devices - Fox News |
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The Food and Drug Administration announced plans to pilot a program meant to put new technology for end-stage renal disease in the hands of patients who need it.
The three products that have been chosen to participate in the FDA’s ‘Innovation Pathway’ program are an implantable renal assist device (iRAD) being developed by the University of California, San Francisco, a wearable artificial kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif., and a hemoaccess valve system (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.
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.
“The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction,” said Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH).
Innovation Pathway, a program that was first announced in 2011, is intended to shorten the time and cost it takes to develop, assess and review medical devices – especially those that could be considered breakthrough treatments.
End-stage renal disease is the loss of kidney function over months or years. Kidneys are essential organs in the body, filtering and removing waste and producing hormones to aid in calcium absorption and red blood cell production. More than half a million Americans suffer from the disease.
Click here to read more from the FDA.
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FDA launches Innovation Pathway 2.0 for pioneering end-stage renal disease ... - Mass Device |
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The FDA's Center for Devices & Radiological Health accepts 3 end-stage renal disease therapy devices in its Innovation Pathway 2.0 program, aimed at speeding pioneering, life-saving devices to market.
The FDA will pilot 3 kidney disease therapy devices through the federal watchdog agency's Innovation Pathway program, aiming to reduce the cost of getting life-saving devices to market.
The watchdog agency selected an implantable renal assist device under development at the University of California in San Francisco, a wearable artificial kidney by Blood Purification Technologies Inc. and a hemoaccess valve system from CreatiVasc Medical.
Each device meets a need in a the end-stage renal market, which Medicare alone paid $29 billion for in 2009, Center for Devices & Radiological Health chief Dr. Jeffrey Shuren said during a conference call today.
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The FDA will launch each project using a team-based approach and dedicated resources, including an assigned case manager to shepherd the devices from early research through clinical studies and finally to the market.
The FDA hopes that, in creating a road-map for review, they can avoid pitfalls for products that are so different from existing devices that decision-makers can't rely on precedent in managing scientific and risk-benefit concerns, often resulting in 4 to 7 years of back-and-forth between the device maker and the agency, Shuren said.
"Because we've done all this work in advance and we've cut out a lot of inefficiencies and we know a lot of the answers in advance, our sense is that many of these applications for the high-risk products are going to be more likely to fall in the category of timeframe that we are trying to achieve, and have yet to have achieved, for our expedited review, and that's approximately 180 days," Shuren said. "That's where we're kind of shooting for."
Although the program focuses on ESRD therapies, the federal watchdog agency plans to apply the lessons learned to future medical device review programs, and potentially to larger government initiatives.
"The FDA, in the course of 6 months, put together an amazing team of the best internal innovators at the centers and external entrepreneurs in residence, who teamed up in lean-innovation mode to put together this incredibly exciting new pathway and news tools that will be utilizable across all of the pre-market programs," the White House's brand-new chief technology officer Todd Park said during the call. "Actually, we've been so enthused about the success that we've been seeking to clone this innovation mode of development across HHS and potentially more broadly across the government as well."
The agency debuted its Innovation Pathway in February 2011 with a military project to create a prosthetic arm controlled by a brain-implanted microchip, granting the device priority review. The FDA announced in January that it would launch Innovation Pathway using its Entrepreneurs in Residence Program, a collaborative initiative aimed at bringing outside experts into the fold, including the recently retired CEO of Medtronic(NYSE:MDT), Bill Hawkins.
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ReCor Medical discloses new data from clinical study of its PARADISE ... - MarketWatch (press release) |
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RONKONKOMA, N.Y., Apr 09, 2012 (BUSINESS WIRE) -- ReCor Medical, an emerging medical device company, disclosed today updated data for the REDUCE First-In-Man clinical study of its PARADISE (Percutaneous Renal Denervation System) ultrasound platform for achieving renal denervation. PARADISE, which is CE-marked, is designed to treat patients with ‘resistant’ hypertension (“HTN”), a major risk factor for cardiovascular disease.
Preliminary F-I-M clinical data for PARADISE were reported previously at the “TRenD 2012” transcatheter renal denervation scientific meeting by cardiologist Thomas A. Mabin, M.D., Vergelegen Medi-Clinic, South Africa. The updated PARADISE data show that systolic blood pressure was reduced by a statistically significant average of 36 mm Hg in 8 patients at 90-days follow-up. The scientific literature demonstrates that only a 5 mm Hg reduction in BP results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in mortality.
“Our PARADISE system is designed to offer a minimally invasive ultrasound therapy to resistant hypertension patients to help reduce their blood pressure,” said Mano Iyer, CEO, ReCor Medical. “These updated clinical data will boost our momentum as we make ready to launch PARADISE in Europe.”
PARADISE includes a 6 French-compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a rapid and highly efficient renal denervation procedure. The advantage of PARADISE is its ability to uniformly denervate all the way around the arterial wall while simultaneously cooling the endothelium, to help enable a safe, consistent, and fast renal denervation procedure.
These updated data were disclosed for the first time to corporate and other investors during a conference call today sponsored by Sanford C. Bernstein & Co., the sell-side research unit of AllianceBernstein L.P. Sanford C. Bernstein was founded in 1967 as an investment-management firm for private clients. Sanford Bernstein is consistently among the most highly ranked independent sell-side research teams, according to industry surveys conducted by third-party organizations.
About ReCor Medical, Inc.
Founded in 2009, ReCor is a private venture-backed, early-stage company developing novel therapeutic ultrasound catheter technology. ReCor is backed by European and U.S. investors including Sofinnova Partners, one of the largest life science investors in Europe. The Company’s PARADISE™ technology for renal denervation is CE-marked. For more information about ReCor Medical, please visit the Company’s website at
www.recormedical.com .
NOTE: PARADISE™ is approved for sale in Europe; it is not approved for sale or investigational use in the United States.
SOURCE: ReCor Medical, Inc.
Ronald Trahan Associates Inc.
Ronald Trahan, +1-508-359-4005,x108
APR, President
Copyright Business Wire 2012
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FDA fast tracks Greenville medical device - Charleston Regional Business |
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Staff Report
Published April 9, 2012
Greenville-based CreatiVasc Medical is one of the first three companies selected nationally to participate in the new Innovation Pathway program of the U.S. Food and Drug Administration.
The program is designed to speed the pace of new medical devices from product development to market.
CreatiVasc developed a valve system device used to treat patients on dialysis, which is a process for removing waste from blood in people with kidney problems.
“Being selected from all the other great companies and universities out there to be part of FDA’s new program reinforces our high expectations for our system and validates the outstanding confidence of CreatiVasc’s local investors,” said Steve Johnson, president and CEO of CreatiVasc.
The company said its device, called the Hemoaccess Valve System, can reduce complications, expense and suffering associated with End Stage Renal Disease patients on dialysis. The primary causes of the disease are diabetes, obesity and hypertension.
The average annual cost of dialysis and its associated complications for the 380,000 dialysis patients in the U.S. is more than $82,000 per patient, according to the 2011 U.S. Renal Data Survey.
Many dialysis patients have a Teflon tube implanted in their arm to provide vascular access for dialysis. Such tubes present a constant challenge because they can clot and require interventional surgery.
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. The device is less prone than others to clotting and early failure, CreatiVasc said.
The valve system device is now in Phase I human clinical trials.
The new FDA program will provide a way for medical device companies and the FDA to collaborate to assure that new technologies are rigorously reviewed but are also guided through the FDA device approval process as rapidly as possible without compromising patient safety.
CreatiVasc and FDA will begin their collaboration in early May. Johnson said he hopes the device would be in the market and available for patients within 24 months.
The FDA selected CreatiVasc’s Hemoaccess Valve System technology because of its potential to improve the quality of life of dialysis patients as well as reduce complications and costly interventional surgery, said Megan Moynahan, associate director for technology and innovation at FDA’s Center for Devices and Radiological Health.
CreatiVasc was founded in Greenville in 2004 by Dr. David Cull, a vascular surgeon with the Greenville Hospital System who developed the new technology. The company began full-time operations in 2007. Since that time, the Hemoaccess Valve System has matured from drawings on paper to a rough prototype to a finished device that is now in Phase I trials at GHS.
“CreatiVasc is excited and honored to be selected as one of the companies for the FDA Innovation Pathway Program,” Cull said. “The program creates a unique partnership between our company and the FDA that will streamline development of our device. This is a great example of how government and the private business sector can work together to advance technology that will benefit patients nationwide.”
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