TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR

Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver. Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT. One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group analysis showed a 100% survival rate and a 1.5% all-stroke rate and a 0.4% rate of disabling stroke at 30 days, the company said. “With its supra-annular and self-expanding design, the Evolut TAVR platform is well-suited to deliver excellent valve performance for intermediate risk patients who are often considered to be more active than high- or extreme-risk patients,” Dr. Nicolas Van Mieghem, of Rotterdam’s Erasmus Medical Center, said in prepared remarks. “As new clinical data are gathered for this patient population, we continue to see the exceptional clinical benefits this self-expanding valve provides as a minimally-invasive treatment alternative to surgery.” Another sub-analysis, of patients stratified according to predicted mortality risk of STS-PROM less than 3%, showed a 1.5% rate of all-cause mortality or disabling stroke at ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news