Medtronic has received CE mark for an expanded indication of its Evolut Transcatheter Aortic Valve Implantation system.
The Dublin-based company said the new indication is for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The Evolut TAVI platform also received a new indication approval that allows for the treatment of patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.
Medtronic said expanded indication approval is based on clinical data from Evolut Low Risk Trial, which evaluated three valve generations (CoreValve, Evolut R and Evolut PRO valves) against SAVR in more than 1,400 patients.
The data showed TAVI to have an excellent safety profile and be an effective treatment option in low-risk patients with shorter hospitals stays and improved 30-day quality-of-life scores compared to surgical valve replacement (surgical valve replacement).
In addition to a lower rate of the composite of all-cause death or disabling stroke with TAVI at 30 days, the Evolut system demonstrated superior hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients and larger EOAs compared to surgery at one year – factors that may be important for more active patients. The rate of new pacemaker implantation and residual aortic regurgitation was higher in the TAVI group.
The approval helps move the needle in the TAVI market, which has been significantly impacted by the COVID-19 pandemic. Medtronic’s rival in TAVI, Edwards Lifesciences reported a steep drop in procedure volume earlier this year.
Edwards also said it would resume the Sapien 3 Ultra rollout as soon as the environment becomes more stable in terms of COVID-19. The company also temporarily paused new enrollments in its mitral and tricuspid clinical trials.