Medtronic won the European CE Mark and is introducing its CoreValve Evolut PRO transcatheter aortic valve in Europe for patients with severe aortic stenosis who are considered at intermediate, high, or extreme risk of not doing well from an open heart surgery.
The Evolut PRO features an external porcine pericardial tissue wrap that helps to make close and solid contact between the prosthetic valve and the natural valve opening. This helps to prevent leakages through and on the side of the implant that can seriously undermine the benefits of having a replacement valve installed.
The valve is delivered using the EnVeo R Delivery Catheter System through vessels as narrow as 5.5 mm.
Certain sizes of the device (23 mm, 26 mm, and 29 mm) received FDA approval earlier this year.
Here’s some details according to Medtronic about the study that led to this approval:
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.