Medtronic's CoreValve Evolut R System Receives CE Mark Approval for Intermediate-Risk Aortic Stenosis Patients

August 1, 2016—Medtronic plc announced European CE Mark approval for the self-expanding, recapturable, and repositionable CoreValve Evolut R transcatheter aortic valve replacement system to treat aortic stenosis patients who are at intermediate risk for open-heart surgery as determined by a heart team.

The CoreValve Evolut R system and the company’s EnVeo R delivery catheter system are now approved for use in patients at extreme-, high-, and intermediate-surgical–risk in Europe and other countries that recognize the CE Mark.

The US Food and Drug Administration approved the device for commercial use in the United States in June 2015 for severe aortic stenosis patients who are at high or extreme risk for surgery. The CoreValve Evolut R system is not approved to treat intermediate risk aortic stenosis patients in the United States, advised the company.

The new intermediate risk indication approval for the CoreValve Evolut R system was based on positive clinical data from the Nordic Aortic Valve Intervention trial (NOTION), and from a subset analysis from the CoreValve United States High Risk Pivotal Trial.

According to Medtronic, data from the NOTION trial showed that comparable clinical outcomes to surgery can be achieved by using CoreValve in patients who are good surgical candidates. Both datasets demonstrated excellent clinical performance for the CoreValve system with lower rates of all-cause mortality and major stroke compared to surgery, and data showed low incidences of procedural complications and superior hemodynamic performance compared to surgery.

In the company’s press release, Prof. Eberhard Grube, MD, commented, “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. 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.” Prof. Grube is Director of the Structural Heart Program at University Hospital in Bonn, Germany.