The FDA approved Medtronic's next-generation CoreValve transcatheter aortic valve replacement (TAVR) device, the Evolut PRO valve, for severe, symptomatic aortic stenosis in patients at high or extreme risk for open surgery, the company Wednesday.
The repositionable, self-expanding valve features an outer biocompatible porcine tissue wrap for increased contact with the native aortic annulus, aiming to reduce paravalvular leak.
Medtronic cited 30-day clinical data from its 60-patient , released last week at the American College of Cardiology meeting in Washington, D.C., showing a 1.7% mortality rate, 1.7% rate of disabling stroke, no severe paravalvular leak, 72.4% of patients with no more than trace leaks, and 11.8% requiring a new permanent pacemaker.
Whereas TAVR devices were the poster child for delayed device marketability, compared with in Europe, CoreValve Evolut PRO came first to the U.S. market and is not approved elsewhere in the world. It is indicated for delivery via vessels down to 5.5 mm and will be available in 23, 26, and 29 mm sizes.