Medtronic has secured CE mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system to treat patients with severe native aortic stenosis who are at low risk of surgical mortality.
The company also secured approval for the Evolut TAVI platform to treat patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.
According to Medtronic, the low-risk patient population is the final surgical risk category to be approved for this minimally invasive alternative to open-heart surgical valve replacement.
The approval allows the TAVI system to treat patients who may be younger and more active than higher-risk patients.
Medtronic TAVI system’s expanded low-risk indication approval was based on data from Evolut Low-Risk Trial
The expanded low-risk indication approval was based on clinical data from the global, prospective, randomised and multi-centre Evolut Low Risk Trial.
Medtronic’s study assessed three-valve generations, including CoreValve, Evolut R and Evolut PRO valves against SAVR in over 1,400 patients.
The data demonstrated that TAVI provided a better safety profile, as well as served as an effective treatment option in low-risk patients with shorter hospitals stays and improved 30-day quality-of-life scores compared to SAVR.
The Evolut TAVI system, which enables to improve heart function, is currently approved in Europe for severe aortic stenosis patients across all risk categories such as extreme, high, intermediate and low.
Its valve has been designed with a self-expanding nitinol frame, which conforms the replacement valve to the native annulus with consistent radial force. It is comprised of an external tissue wrap that increases surface area contact with native anatomy for enhanced valve sealing.
The Evolut TAVR platform is approved in the US for symptomatic severe aortic stenosis patients across all risk categories.
Medtronic cardiac and vascular group’s structural heart and cardiac surgery businesses chief medical officer and vice president Dr Pieter Kappetein said: “With these approvals, more patients will now be candidates for the Evolut TAVI system while surgical aortic valve replacement will evolve to serve a more complex patient population.
“Medtronic is well positioned to provide a variety of therapy options to meet the varying needs of patients with heart valve disease.”
Recently, Medtronic secured CE mark approval for its MiniMed 780G hybrid closed loop insulin pump system to treat type 1diabetes in people aged between seven and 80 years.
