FDA combats criticisms over speed with ESRD pathway

Many critics have accused the FDA of being too slow in ushering new devices to market. But the agency is now looking to combat this assertion. To that end, the FDA has announced a pathway designed to get devices for end-stage renal disease (ESRD) patients to the market "in a safe, timely and collaborative manner."

The ESRD products will be the focus of the second version of the Innovation Pathway, first announced last year to shorten the time and cost it takes for the development, assessment and review of breakthrough medical devices.

Kidney disease patients aren't the only ones emerging as winners as a result of the FDA's announcement. The agency chose three applications from a field of 32 after a January request from its device center to test out the pathway.

The three winning products are an implantable renal assist device being developed by the University of California, San Francisco; a wearable artificial kidney from Beverly Hills, CA-based Blood Purification Technologies; and a hemoaccess valve system designed by CreatiVasc Medical of Greenville, SC.

And it could mark a major turning point for small companies trying to get their products to the market. "For a small company, when you talk about shortening 6 months to a year, that is significant because you're talking about a significant amount of capital," said Steve Johnson, president and CEO CreatiVasc Medical, as quoted by Bloomberg.

According to the Charleston Regional Business Journal, CreatiVasc's tech is less prone than others to clotting and early failure and is now in Phase I clinical trials.

So why ESRD in particular? According to the agency, more than half a million people in the U.S. suffer from the disease. And it is a costly condition: Medicare covers roughly 75% of ESRD health care costs, which topped $29 billion in 2009.

But the agency doesn't plan to stop with ESRD devices. It will take what it learns from the kidney program and apply it to future device review programs, MassDevice notes.

The first time the FDA tested the fast-track program was with a brain-controlled prosthetic under development by the Defense Department. Its Defense Advanced Research Projects Agency worked about four months with the FDA to construct a development path, according to Bloomberg.

- see the FDA's release
- check out more from Bloomberg
- read the story from the Charleston Regional Business Journal
- check out more from MassDevice

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