US FDA Green-Lights Medtronic's CoreValve Evolut For Intermediate Risk
The approval, based on the results of the SURTAVI trial, comes a few months ahead of analysts' expectations and is welcome news for Medtronic in its effort to keep pace with TAVR leader Edwards in the US market.
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The first half of November was full of cardiovascular device news, led by clinical trial results from renal denervation and transcatheter aortic valve trials presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
The five-year results from the US pivotal high-risk trial of Medtronic's CoreValve transcatheter aortic valve, the longest-term follow-up data from a randomized trial of CoreValve, show the valve remains durable with low rates of severe hemodynamic structural valve deterioration compared to surgical valves.
EuroPCR 2018: Real-World TAVR Data Show Consistent Performance With Edwards, Abbott, And Medtronic's Systems
New real-world data on Edward Lifesciences real-world data for its transcatheter aortic valve replacement Sapien 3 valve are among the highlights from the early Hot Line/Late-Breaking Trial sessions at the EuroPCR conference in Paris.