MEDTRONIC ANNOUNCES CE MARK AND LAUNCH OF NEW RECAPTUREABLE TAVR SYSTEM AVAILABLE FOR SEVERE AORTIC STENOSIS PATIENTS WITH LARGE ANATOMIES
Available in Norway, New 34 mm Self-Expanding Evolut R Device Expands TAVR Treatment to Patients Who Could Not be Treated Previously
Medtronic plc (NYSE:MDT) today announced the CE (Conformité Européenne) mark and European launch of the CoreValve™ Evolut™ R 34 mm valve—the largest sized transcatheter aortic valve replacement (TAVR) system available in Norway. The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 25-30 percent of the eligible global TAVR patient population. Previously, some of these patients were unable to receive a TAVR due to the larger size of their native diseased aortic valve.
The Evolut R 34mm valve is delivered through the EnVeo™ R Delivery Catheter System, which features an InLine Sheath. The system delivers the lowest, true delivery profile currently on the market (16 Fr equivalent, approximately 1/5 inch), which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. The Evolut R System, with its self-expanding nitinol frame, is designed to fit within the native aortic valve, using its supra-annular valve position to help achieve excellent hemodynamic performance.
The CoreValve Evolut R 34 mm valve was approved in the United States in October 2016.
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