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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