News | Heart Valve Technology | January 17, 2017

Medtronic Announces CE Mark, European Launch of CoreValve Evolut R 34 MM Valve

Larger device offers treatment to patients without a previous TAVI option

Medtronic, CoreValve Evolut R 34 mm valve, TAVI, CE Mark, European launch

January 17, 2017 — Medtronic plc announced the CE (Conformité Européenne) mark and European launch of the CoreValve Evolut R 34 mm valve — the largest sized transcatheter aortic valve implantation (TAVI) system available in Europe. The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at intermediate, 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 20-25 percent of the eligible European TAVI patient population. Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve.

“It’s important that patients with large aortic root anatomies can also have access to this recapturable TAVI system, which has proven to be an excellent treatment option for many patients,” said Darren Mylotte, M.D., interventional cardiologist at the University Hospitals and National University of Ireland in Galway, Ireland. “Consistent with the Evolut R platform, the 34 mm valve delivery system assists with accurate placement with the option to recapture and reposition if needed; this gives physicians great confidence that exceptional outcomes can be achieved for our patients.”

The 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 according to Medtronic (16 Fr equivalent, approximately 1/5 inch or 1/2 cm), 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 received U.S. Food and Drug Administration (FDA) approval in the United States in October 2016 for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm.

For more information: www.medtronic.com

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