Medtronic has announced that its CoreValve Evolut transcatheter aortic valve replacement platform, consisting of CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, is now FDA approved for patients with “symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.” Previously, the products were only approved for high and extremely risky patients that are not good candidates for an open-heart surgery. The company touts data pointing to its transcatheter valves as having better hemodynamic characteristics compared to surgically implanted devices, and the new approval signals a direction whereby more and more patients will benefit from avoiding heart surgeries.
Here’s some details from a study evaluating CoreValve Evolut in intermediate-risk patients, according to Medtronic:
Recently unveiled at the 2017 American College of Cardiology meeting, the global SURTAVI trial evaluated intermediate-risk patients and compared 863 TAVR patients treated with the CoreValve and Evolut R Systems (STS: 4.4 percent) to 794 surgical patients (STS: 4.5 percent). Against the strongest surgical performance (compared to predicted surgical risk of mortality) seen to date in a randomized trial, the CoreValve Evolut platform met its primary endpoint of non-inferiority compared to surgery in all-cause mortality or disabling stroke (12.6 percent for TAVR versus 14.0 percent for SAVR; posterior probability of non-inferiority >0.999). The CoreValve Evolut platform also demonstrated significantly better mean aortic valve gradients (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years. SAVR was associated with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation.
Product page: Evolut…
Via: Medtronic…