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FDA Approves New Version of Transcatheter Heart Valve Device
The FDA has give the green light to the CoreValve Evolut R system (Medtronic) for transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who are at high or extreme risk for surgery.
The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeoR delivery system, which features an InLine sheath that reduces the profile to less than 1/5 inch. A smaller profile size provides a greater opportunity to treat an expanded patient population with smaller vessels (down to 5.0 mm) through the preferred transfemoral access route, which may minimize the risk of major vascular complications in some patients, according to the manufacturer. An extended sealing skirt on the 26-mm and 29-mm valve sizes is intended to further promote valve sealing at the annulus.
In March, initial clinical outcomes for the CoreValve Evolut R system were presented at the 64th annual scientific session of the American College of Cardiology. At 30 days, all recapture attempts were performed safely with no strokes. In addition, correct valve position with one device was achieved in 98.3% of patients, and there were no cases of valve dysfunction, procedural death, annular rupture, coronary occlusion, valve embolization, or conversion to surgery. The pacemaker rate was low at 11.7%.
The approval of the Evolut R system makes it the first self-expanding, recapturable transcatheter heart valve available in the U.S. It comes in 23-mm, 26-mm, and 29-mm sizes.