Wednesday, October 25, 2023
Medtronic, a global leader in healthcare technology, has unveiled the results of its Evolut Low Risk Trial, spanning a four-year period. The data reveals the remarkable performance of the Medtronic Evolut™ transcatheter aortic valve replacement (TAVR) system, showcasing significantly improved hemodynamics compared to surgical aortic valve replacement (SAVR). Notably, only the Evolut TAVR system has consistently reported lower rates of death or disabling stroke compared to state-of-the-art surgery at the four-year mark.
The Evolut™ Low Risk Trial was a prospective, randomized, multicenter, international study that aimed to assess the safety and effectiveness of the Evolut TAVR system versus surgical aortic valve replacement (SAVR) in low-risk patients. Low-risk patients, as defined in the trial, had a predicted 30-day mortality risk of less than 3% according to the local heart team assessment. A total of 1,414 patients participated in the trial, with 730 undergoing TAVR and 684 undergoing SAVR.
The data unveiled today at TCT underlines Medtronic's commitment to producing evidence on the effectiveness of its Evolut TAVR platform. This research provides crucial treatment options for low-risk patients with symptomatic severe aortic stenosis, addressing a growing patient population.