Medtronic has received the CE mark for the Evolut FX transcatheter aortic valve implantation (TAVI) system, its new-generation TAVI system of the CoreValve/Evolut TAVI platform.
The Evolut FX system is indicated for the treatment of severe aortic stenosis in adults, across extreme, high, intermediate, and low-risk categories, in the European Union (EU).
The system is designed to provide clinicians with enhanced precision and control throughout the procedure for treating patients with severe aortic stenosis.
It incorporates the same self-expanding valve design as the CoreValve/Evolut platform, with superior hemodynamic performance compared to surgical aortic valve replacement (SAVR).
The CoreValve/Evolut is the only TAVI platform to show a durability advantage over SAVR in three separate large-scale randomised controlled trials, said the medical device company.
Medtronic coronary and renal denervation business and structural heart and aortic business vice president and chief medical officer Jeffrey Popma said: “This exciting milestone helps us continually enhance a trusted platform to better respond to clinicians’ needs making TAVI procedures easier to visualize and more predictable for heart teams.
“Receiving CE Mark for the Evolut FX system highlights our commitment to providing minimally invasive treatment options globally for patients experiencing severe aortic stenosis.”
Severe aortic stenosis occurs when the aortic valve leaflets are thickened and are difficult to open and close, making the heart work harder to pump blood to the rest of the body.
It often impacts a patient’s quality of life, limits their daily activities, and may lead to death from heart failure within two years, if left untreated.
Evolut FX is the fourth-generation system that features gold markers built into the frame to provide direct visualisation of depth and valve leaflet orientation during the implant.
Also, it features a redesigned catheter to enable a smooth insertion profile and a more flexible delivery system for a stable, predictable deployment.
Medtronic intends to commercialise the Evolut FX system across Europe in the coming weeks, after physicians and their teams are trained on the new technology.
