Medtronic announces results from CoreValve U.S. Pivotal Extreme Risk Study
Medtronic announced outcomes from the CoreValve U.S. Pivotal Extreme Risk Study and the real-world Notion trial, both of which examined patients with the CoreValvetrans catheter aortic valve replacement system at five years post-implant. Results from the studies demonstrated that patients implanted with the CoreValve TAVR system showed "strong hemodynamic performance and improved quality of life out to five years," the company said, The physician-initiated trial studied an all-comers population of 280 patients at least 70 years old who were randomized to surgical or transcatheter aortic valve replacement using the CoreValve System. Results at five-year follow-up showed similar rates of all-cause mortality and superior hemodynamic performance for TAVR compared to surgery, Medtronic added. Also presented were the final five-year results from the CoreValve U.S. Pivotal Extreme Risk Study, which enrolled the first US IDE cohort of patients ever to be treated with the self-expanding CoreValve TAVR system. Results from the study continued to show positive outcomes at five years for the surviving patients - all of whom were deemed to be facing considerable harm or mortality with a surgical valve replacement, according to Medtronic. Patients implanted with the CoreValve system maintained a notable improvement in quality of life and sustained low mean gradients.