GREENVILLE, S.C., April 9, 2012 /PRNewswire-USNewswire/ --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.
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 frequently clot and require costly interventional surgery. According to a study published in the New England Journal of Medicine, more than 75% of dialysis grafts fail and require surgical intervention within the first year after placement. Early research shows that the CreatiVasc Hemoaccess Valve System allows selective blood flow into these grafts only when it is needed for dialysis, which is believed to reduce such universal complications.
The new FDA program will provide a totally new way for medical device companies and FDA to collaborate to assure that promising new technologies are rigorously reviewed but are also guided through its device approval process as rapidly as possible without compromising patient safety.
CreatiVasc was founded in Greenville, S.C., in 2004 by Dr. David Cull, a vascular surgeon with the Greenville Hospital System who developed the new technology after seeing first-hand the problems associated with traditional dialysis-access grafts. The company began full-time operations in 2007. The company has multiple issued patents on the device both in the U.S. and around the world.
SOURCE Greenville Hospital System