FDA recommends approval of Edwards Sapien transcatheter valve


FDA’s Advisory Panel voted on 20 July 2011 to recommend approval of the Sapien transcatheter heart valve (Edwards Lifesciences) for the treatment of certain inoperable patients. 

Edwards submitted a pre-market application in the fall of 2010 based on data from the inoperable cohort of the PARTNER study (Placement of aortic transcatheter valve trial). This cohort compared the outcomes of 358 patients after treatment with either standard therapy or the Sapien valve delivered transfemorally.

“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,” said Michael A Mussallem, Edwards’ chairman and CEO. “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.”

The Sapien valve is an investigational device in the USA and is not commercially available in this country. It received CE mark approval in 2007.