Medtronic (NYSE:MDT) said today it won expanded CE Mark approval in the European Union for its CoreValve Evolut R transcatheter aortic valve replacement, now approved for aortic stenosis patients at intermediate risk for open-heart surgery.
The Fridley, Minn.-based company touted the win, saying it is the 1st TAVI system to have received expanded indication in Europe for patients at intermediate risk for open heart surgery.
“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 TAVI access to younger and less sick patient populations,” Dr. Eberhard Grube of Bonn, Germany’s University Hospital said in a press release.
The new indication was based on clinical data from the Nordic aortive valve intervention trial which showed comparable clinical outcomes to surgery with use of the CoreValve in patients who are good surgical candidates, Medtronic said.
“This first-of-its-kind TAVI indication in Europe further demonstrates Medtronic’s global leadership in the transcathether valve space and commitment to extending these benefits to new patient populations through rigorous clinical research and exceptional physician training and education. We are continuing to support global heart teams with training and education on the Evolut R System to expand patient access to this minimally-invasive treatment option,” heart valve therapies biz GM Rhonda Robb said in prepared remarks.
CoreValve Evolut R originally won CE Mark approval in the European Union in September 2014. The FDA granted pre-market approval last June.
In April, Medtronic said it launched another clinical trial for its CoreValve Evolut R replacement heart valve, aiming to win an expanded indication for low-risk patients.
The 1,200-patient trial is designed for patients with less than 3% risk of dying from open valve surgery, randomized to either transcatheter aortic valve replacement with the CoreValve device or surgical aortic valve replacement. It’s the 3rd trial for Medtronic’s TAVR offering since February, when the FDA approved the new investigational device exemption study.
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