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TAVR system receives CE mark for intermediate-risk patients

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The CoreValve Evolut R transcatheter aortic valve replacement system has been approved in Europe for use in patients with aortic stenosis who are at intermediate risk for surgery, according to a Medtronic press release.

This is the first TAVR system to obtain an expended indication in Europe for this patient population, according to the company.

CE marking was based on positive clinical data from the NOTION trial and from a subset analysis of the CoreValve U.S. High Risk Pivotal Trial. In NOTION, patients at low and intermediate risk for surgery assigned TAVR or surgical AVR had similar composite rates of all-cause death, stroke or MI, according to the release.

“The unique design of the self-expanding, supra-annular Evolut R System, coupled with its ability to be recaptured and repositioned for accurate valve placement, enables this device to be a viable treatment alternative for patients at intermediate surgical risk,” Eberhard Grube, MD, director of the Structural Heart Program at University Hospital in Bonn, Germany, stated in the release. “The highly anticipated intermediate-risk indication marks an important milestone for the industry as we look to safely expand [TAVR] access to younger and less-sick patient populations.”

The CoreValve Evolut R System is now approved for use in patients at extreme, high and intermediate surgical risk in Europe and other countries that recognize the CE mark. The system was FDA approved for commercial use in the United States in June 2015 for patients with aortic stenosis who are at high or extreme risk for surgery; it is not approved to treat intermediate-risk patients in the United States at this time.

In the United States, the FDA in February approved an expanded indication trial to investigate whether the CoreValve Evolut R System will be more effective than surgery for patients with aortic stenosis who are at low surgical mortality risk, as determined by a heart team.

Disclosure: Cardiology Today Intervention could not confirm relevant financial disclosures.