Medtronicâ??s CoreValve Evolut Transcatheter Aortic Valves **w Approved for Intermediate Risk Patients Medtronic has an**unced that itsآ*CoreValve Evolut Transcatheter Aortic valve replacement platform, consisting ofآ*CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, is **w FDA Approved for patients with “symptomatic severe Aortic ste**sis who are at an intermediate risk for open-heart surgery.” Previously, the products were only Approved for high and extremely risky patients that are **t 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:
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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 **n-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 **n-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
07-12-2017, 12:30 AM
Medtronic’s CoreValve Evolut Transcatheter Aortic Valves **w Approved for Intermedi
Medtronic has an**unced that itsآ*CoreValve Evolut Transcatheter Aortic valve replacement platform, consisting ofآ*CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, is **w FDA Approved for patients with “symptomatic severe Aortic ste**sis who are at an intermediate risk for open-heart surgery.” Previously, the products were only Approved for high and extremely risky patients that are **t 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.
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