Kidney Failure Devices to Receive Fast-Track FDA Reviews

A wearable artificial kidney and two other devices to treat renal failure will get fast-track reviews under a program U.S. regulators say can cut the time it takes to get “breakthrough” medical technology to market.

The Food and Drug Administration chose the three devices -- a valve system, an implant and the artificial kidney -- from 32 applications competing to be in the expedited-review program, the agency said in a statement today. The FDA proposed the Innovation Pathway, a priority review process for “new, breakthrough medical devices,” in February 2011.

End-stage kidney disease is “a natural fit given that patients have few options,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

Innovation Pathway can cut in half to 150 days the time for the most-stringent review process for higher-risk devices, the FDA said. Reviews will be shorter because the agency and device manufacturers meet early in development to plan clinical trial designs that will most likely result in approval, Megan Moynahan, acting associate director for technology and innovation at the FDA, said on a conference call with reporters.

“For a small company, when you talk about shortening six months to a year, that is significant because you’re talking about a significant amount of capital,” said Steve Johnson, who works for Greenville, South Carolina-based CreatiVasc Medical LLC, a closely held company designing a hemoaccess valve system.

Regulatory Hurdles

CreatiVasc’s device is in the first stages of development, Johnson said on the call. Blood Purification Technologies Inc. in Beverly Hills, California, is making the wearable artificial kidney, while the University of California, San Francisco, is working on the implantable kidney device, according to the FDA.

Device manufacturers in the program will be assigned a case manager who will shepherd them through the development process and bring in outside advisers to help manage scientific and regulatory hurdles, Shuren said.

The agency has “a handful” of other kidney failure devices on a wait list, Moynahan said. The FDA also plans to issue a challenge to device manufacturers to treat another disease to take advantage of the pathway, Shuren said. He declined to specify the disease because it’s under discussion.

The agency plans to incorporate aspects of Innovation Pathway that work well into its normal review process. The medical device industry agreed in February to a doubling of the fees they pay the FDA to get products reviewed over the next five years to $595 million. The additional fees will help speed reviews and enable more meetings with the agency during the middle of the process to give companies time to address concerns.

The FDA first tested the fast-track program with a brain-controlled, upper-extremity prosthetic still in development by the U.S. Defense Department. The department’s Defense Advanced Research Projects Agency spent 120 days collaborating with the regulator to map its development path.

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