Medtronic's CoreValve Evolut Pro TAVR Device Approved in Europe
July 31, 2017—Medtronic announced CE Mark approval and the European launch of the CoreValve Evolut Pro valve for transcatheter aortic valve replacement (TAVR) treatment of severe aortic stenosis in symptomatic patients who are at intermediate, high, or extreme risk for open heart surgery.
The Evolut Pro device is built on the recapturable CoreValve Evolut R system and includes a self-expanding nitinol frame and a supra-annular valve position. The device's outer wrap adds surface area contact between the valve and the native aortic annulus to improve valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.
The Evolut Pro system is delivered through the EnVeo R delivery catheter system and is indicated for vessels down to 5.5 mm in size. In Medtronic's announcement, Nicolas M. Van Mieghem, MD, commented, "The Evolut Pro valve has shown impressive clinical outcomes, with low paravalvular leak and pacemaker rates. With its ease-of-use and deliverability, the Evolut Pro valve will bring TAVR practice to a higher level, and I look forward to seeing it utilized in patients across Europe." Dr. Van Mieghem is Director of Interventional Cardiology at Erasmus Medical Center in Rotterdam, The Netherlands.
In March, the company announced that the 23-, 26-, and 29-mm sizes of the Evolut Pro system received US Food and Drug Administration approval and are available for use in the United States.
Medtronic noted that clinical data for the Evolut Pro valve were recently presented at the American College of Cardiology's 66th annual scientific session, and showed high survival, low rates of stroke, minimal paravalvular leak (PVL), and excellent hemodynamics.
The company advised that the Evolut Pro Clinical Study (N = 60) met its primary endpoint at 30 days with high rates of survival (98.3%) and low rates of disabling stroke (1.7%). The Evolut Pro valve also showed strong hemodynamic performance with large aortic valve areas (2 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days.
The majority of patients in the study (72.4%) experienced no/trace PVL and no incidents of moderate or severe PVL were observed at 30 days. Additionally, improving on the already low rates seen in Evolut R clinical studies and real-world TVT and FORWARD registries, the rate of new pacemaker implantation was 10%, stated Medtronic.