MEDTRONIC ANNOUNCES CE MARK AND LAUNCH OF NEW RECAPTUREABLE TAVR SYSTEM AVAILABLE FOR SEVERE AORTIC STENOSIS PATIENTS WITH LARGE ANATOMIES
Available in Sweden, 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 Sweden. 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.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Medtronic är ett ledande internationellt företag inom medicinsk teknik. Vi utvecklar medicintekniska produkter och behandlingar för att hjälpa patienter och förbättra deras livskvalitet