The FDA's Circulatory System Devices Committee gave Edwards Lifesciences ($EW) a win Wednesday with a vote recommending the devicemaker's Sapien transcatheter heart valve after an epic session. The panel voted 9-0--with one member abstaining--that the device's benefits outweighed its risks, 7-3 in favor of its safety, and 9-1 for its effectiveness. The FDA will make a decision on the valve at a later date.
The Sapien valve would be used in patients who are ineligible for open aortic valve replacement. But, as Forbes' Cardiobrief blog notes, the FDA and panel members were concerned the enthusiasm about the device could lead to a stampede of early usage in patients--even those who were non-ideal candidates.
Earlier in the week, the FDA released a report showing the valve, which can be implanted without major surgery, significantly reduced death rates versus standard therapy in people with severe aortic stenosis. However, there was a higher incidence of major strokes and major vascular events seen in the group receiving the Sapien valve in a study.
Indeed, neurological events represented a major issue in the meeting, as heartwire notes, with several panel members pointing out that older, frail patients are far more concerned about strokes than death. Furthermore, mortality reduction with TAVI is, as the FDA terms it, impressive, but most treated patients die within two years. That said, panel members concluded that the benefits of transcatheter valve replacement in these frail patients offset the stroke risk.
"We are pleased with the panel's strong recommendation for approval, and would like to thank them for their comprehensive and thoughtful review of the data presented from The PARTNER Trial. This represents another important step on the path to what we hope will lead to FDA approval of SAPIEN," Michael Mussallem, Edwards' chairman and CEO, says in a statement. "We would also like to thank the principal investigators and their heart teams at the PARTNER hospitals for their dedication to this clinical trial, and to their patients for participating in a study of a new therapy."
Edwards has marketed Sapien in Europe since 2007 and could start selling it in the U.S. in Q4. Analysts note the worldwide market for heart valves could ultimately grow to $2 billion in annual sales, as the Orange County Business Journal reports.