FDA Approves Second Generation Heart Valve From Edwards Lifesciences

June 16, 2014 10:26 PM

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The next phase of the burgeoning and rapidly maturing transcatheter aortic valve replacement (TAVR) market has begun. Edwards Lifesciences announced on Monday afternoon that the FDA had approved its second generation Sapien XT TAVR device for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS).

The Sapien XT is the successor to the first generation Sapien device, which offered the first nonsurgical approach to aortic valve replacement. A competing device, Medtronic’s CoreValve, was approved earlier this year and has gained considerable interest. The Sapien XT is expected to be more competi...

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