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Edwards Lifesciences Bullish on TMVR But Scant on Details

Edwards Lifesciences is betting on a big opportunity in transcatheter mitral valve replacement, but offers up very few details on the status of its efforts in that area.

Edwards Lifesciences is betting on a big opportunity in transcatheter mitral valve replacement, but offers up very few details on the status of its efforts in that area. 

Arundhati Parmar

Edwards Lifesciences continued to wow analysts with its transcatheter heart valve sales results on its earnings call on Monday, but to a certain extent the attention of analysts has shifted to what they hope will be the next thing pushing revenue higher: Transcatheter mitral valve replacement.

While acknowledging that Edwards' $296.1 million sales in transcatheter heart valves was impressive, analyst after analyst tried to pry details of the company's TMVR program. But they didn't get much.

Here's what we do know about Edwards's TMVR program, according to a transcript of the call from Seeking Alpha:

  • The internal Fortis TMVR program has been largely jettisoned and the feasibility trial testing it has been stopped
  • The Fortis team is being integrated with the CardiAQ team, which came to Edwards after it acquired the TMVR startup in August for about $400 million.
  • The CardiAQ Edwards Valve will essentially be the CardiAQ Valve although Edwards will develop additional sizes, refine delivery systems and add its bovine, pericaricardial tissue in the future.

Analysts pushed for more - when would the TMVR program contribute to revenue? When would the feasability study in the U.S. and the trial for obtaining CE Mark launch? What aboutr transmitral repair - would the market see a repair device on a similar time frame as the replacement device?

But Mussallem wasn't able to satisfy their curiosity preferring instead to outline TMVR as a "big opportunity" without giving dates for studies or revenue expectations. He noted that it is a " little early to be talking about when sales might happen and exactly how big that would be" stressing that gaining clinical experience is the current priority. More details on the TMVR program will be forthcoming in early December when the Irvine, California company hosts 2015 investor conference. 

Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected] and on Twitter @aparmarbb

To learn about medical device industry trends, visit the Lifescience Alley and MD&M Minneapolis conference, Nov. 4 and 5 at the Minneapolis Convention Center. 


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