September 25, 2016
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Balloon-expandable TAVR system approved for intermediate-risk patients in Europe

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Edwards Lifesciences announced its newest-generation balloon-expandable transcatheter aortic valve replacement system, has received a CE mark to extend its use for patients with severe aortic stenosis at intermediate risk for surgery.

The valve (Sapien 3, Edwards Lifesciences) was first approved in Europe in January 2014 for use in patients at high-risk for open-heart surgery, the company stated in a press release.

According to the release, in intermediate-risk patients, the valve has been shown to be superior to surgery for the composite outcome of mortality, stroke and moderate-to-severe aortic regurgitation.

“This expanded intermediate-risk indication allows for the treatment of even more patients whose only previous option was an open-heart surgical procedure,” Helge Möllmann, MD, director for the Clinic for Internal Medicine at St. Johannes Hospital in Dortmund, Germany, said in the release. “I am encouraged by the adoption of the position paper of the German Cardiology Society that recommends the use of [TAVR] in intermediate-risk patients based on growing clinical evidence.”

The FDA approved the valve for the treatment of intermediate-risk patients in August.

Disclosure: Möllmann reports speaking for and receiving proctor honoraria from Abbott, Edwards Lifesciences, St. Jude Medical and Symetis.