FDA approval of 34mm CoreValve Evolut R means device is largest available TAVI valve in USA

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CoreValve Evolut R
CoreValve Evolut R

Medtronic has announced the FDA approval and US launch of the CoreValve Evolut R 34mm valve—the largest sized transcatheter aortic valve implantation (TAVI) system available in the USA. The new Evolut R 34mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26mm to 30mm. This large valve segment is estimated to account for approximately 25–30% of the eligible global 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.

The Evolut R 34mm valve is delivered through the EnVeo R delivery catheter system, which features an InLine Sheath. A press release reports that the system delivers the lowest, true delivery profile currently on the market (16Fr equivalent, approximately 1/5inch), which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. It adds that 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 haemodynamic performance.

Mathew Williams, co-primary investigator for the Evolut 34mm clinical Study, and chief of Adult Cardiac Surgery and director of Interventional Cardiology and the Heart Valve Program at the NYU Langone Medical Center in New York City (USA), says: “We are pleased to have more options to offer patients suffering from severe aortic stenosis who are at high risk or unable to have open-heart surgery. This new, larger valve offers patients with larger anatomical structures access to TAVI. For physicians, the recapturable and repositionable Evolut R can lead to increased accuracy in placement and control during the procedure.”

The CoreValve Evolut R 34mm valve is only approved in the USA and not approved in Europe and other countries.