Medtronic received FDA approval for its CoreValve Evolut Pro transcatheter valve for implantation into symptomatic patients with severe aortic stenosis who are too fragile for open heart surgery.
The self-expanding valve is based on the CoreValve Evolut R, and has a porcine pericardial tissue wrap that makes contact with the native valve and promotes a good seal. It can be delivered via vessels as small as 5.5 mm using the EnVeo R catheter system, and the implant is available in 23 mm, 26 mm and 29 mm sizes.
Here’s some details of a study of the CoreValve Evolut Pro, according to Medtronic:
The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The majority of study subjects (72.4 percent) 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 percent.