Edwards Finds Transcatheter Valve Adoption In U.S. Slower Than Expected
This article was originally published in The Gray Sheet
Edwards Lifesciences is lowering its revenue expectations for 2013 based on adoption rates so far of its transcatheter aortic valve implant technology.
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Edwards Lifesciences reported 19 percent year-over-year growth in worldwide sales of its Sapien transcatheter aortic valve systems during the second quarter of 2014. The company cites the ongoing launch of the Sapien 3 system in Europe and Sapien XT in the U.S. as keys to continuing growth.
Edwards is counting on the Sapien XT valve, which will likely earn FDA approval soon, to compete with Medtronic’s recently approved CoreValve in the U.S, while in Europe the company is working quickly to upgrade customers to Sapien 3.
The firm now expects to gain approval for the extreme-risk indication of its transcatheter aortic heart valve months earlier than earlier predicted following well-received pivotal trial data reported last week at the Transcatheter Cardiovascular Therapeutics meeting.