FDA approves Medtronic’s CoreValve Evolut R


Medtronic has announced that the FDA has approved its recapturable, self-expanding CoreValve Evolut R transcatheter aortic valve implantation (TAVI) system—making it the first-and-only recapturable and repositionable device available in the USA. The system is approved for the management of severe aortic stenosis patients who are at high or extreme risk for surgery.

According to a press release, the CoreValve Evolut R system is built on the proven foundation and procedural success of the CoreValve system (which has been implanted in more than 75,000 patients in 60 countries).

The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R delivery system, which features an InLine sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch). The press release reports that a smaller profile size provides a greater opportunity to treat an expanded patient population with smaller vessels (down to 5mm), through the preferred transfemoral access route, which may minimise the risk of major vascular complications in some patients.

Mathew Williams, chief of Adult Cardiac Surgery and director of Interventional Cardiology and Structural Heart at the NYU Langone Medical Center, New York, USA, says: “Clinical data have shown the best patient outcomes are achieved when the [TAVI] valve is properly positioned. The advancement of recapturability with Evolut R gives physicians more confidence during the procedure and provides advantages that are non-existent in other TAVI systems.”

The 23 mm, 26 mm and 29 mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R delivery catheter system are available for use in the USA. The device is also available in Europe and other countries that recognise the CE mark.