Panel Supports Sapien But Urges Cautious Rollout
This article was originally published in The Gray Sheet
Edwards Lifesciences’ Sapien transcatheter aortic valve met widespread expectations last week by gaining support for FDA approval from an agency advisory panel, but the experts urged FDA and Edwards to proceed cautiously.
You may also be interested in...
New research on bariatric surgery and transcatheter heart valve implantation.
Edwards Lifesciences is still waiting on an approval decision from FDA on the first indication for its Sapien transcatheter aortic heart valve replacement, but CMS has decided not to wait.