FDA approves CoreValve Evolut Pro Transcatheter Aortic Valve

Aortic stenosis is a type of disease that causes tapering of the aortic valve opening. It limits the flow of the blood flow to the aorta from the left ventricle and can also have an impact on the pressure in the left atrium. Recently, Medtronic received a nod from Food and Drug Administration for its CoreValve Evolut Pro transcatheter valve. The device can be used for implantation into indicative patients with severe aortic stenosis who are too weak to undergo an open heart surgery. The approval was achieved after a analyzing the data from the 30-day clinical trial that demonstrated low stroke rates, high survival, minimal paravalvular leak, and outstanding hemodynamics for the self-expanding valve.

The Evolut PRO device is presented with a unique valve design that has a porcine pericardial tissue wrap, which adds surface area contact between the native aortic annulus and the valve to further enhance the valve sealing performance. The tissue wrap is integrated to tackle the incident of blood leaking via the valve sides.

The Evolut PRO Clinical Study, which included 60 study participants, attained its primary endpoint at 30 days with 98.3% survival rate and 1.7% disabling stroke rate. The study also illustrated a strong hemodynamic performance with large, i.e., 2.0±0.5cm2 aortic valve area and mean gradients of 6.4±2.1mmHg. No events of severe or moderate minimal paravalvular and no/trace minimal paravalvular leak were observed in a majority of the participants.

The Evolut PRO valve, which is constructed on the already validated platform of the recapturable CoreValve Evolut R System, consists of a nitinol frame that can expand on its own with its supra-annular valve position, which assists in achieving an outstanding hemodynamic performance.

The Evolut PRO System is implanted via the EnVeo R Delivery Catheter System, which is specified for vessels below 5.5mm. The EnVeo R system is provided with an InLine Sheath that makes it, at present, the low-cost delivery platform in the market. It also offers a huge opportunity for treating patients with smaller vessels via the favored transfemoral access route. The device is available in different sizes such as 29mm, 26mm, and 23mm.

This device will help the patients who cannot undergo an open heart surgery. Isn’t it?