Edwards Lifesciences (NYSE:EW) said the FDA set a date for its circulatory devices advisory panel to review a pre-market approval application for its Sapien heart valve.
The Irvine, Calif.-based medical device maker already has a PMA for the Sapien device for treating lower-risk heart disease patients. The device, a transcatheter aortic valve implant, is an alternative to open heart surgery.
The second PMA application is for higher-risk patients. The application is backed by data from the 699-patient Cohort A of the Partner trial, comparing surgical valve replacement with a TAVI procedure.
The advisory panel’s June 13 meeting will consider the Partner-A data Edwards presented at the American College of Cardiology’s annual meeting last month, showing that the procedure stood up to surgical valve replacement after 2 years, but was also more prone to a type of valve leakage that could cause death. All-cause mortality for high-risk TAVI patients was 33.9% in the Partner A trial, compared with the 35% rate among patients who received open-heart surgery for aortic valve replacement. The study also confirmed a lower stroke rate among TAVI patients, findings that were reiterated inMedtronic’s Advance TAVI trial and a Canadian registry of Sapien patients.
The news helped Edwards regain a small portion of the value lost on Wall Street’s delayed reaction to new U.S. job numbers last week, when the markets were closed for the Easter holiday. EW shares were trading at $71.29 as of about 11 a.m. today, up a hair on the day but still down 0.01% compared with an April 5 close of $71.99.
