The European Union has granted CE mark approval to Medtronic's new transcatheter aortic valve implantation (TAVI) system with transapical delivery catheter, for the treatment of patients with severe aortic stenosis who are at high or extreme risk of surgical aortic valve replacement (SAVR).
Using a minimally-invasive delivery system via a catheter, the Engager TAVI system is inserted in the apex (the lower, pointed end) of the heart to promote annular sealing and minimise paravalvular leak (PVL).
Comprised of bovine tissue leaflets and a self-expanding nitinol frame, the valve's control arms simplify implantation, and the supra-annular valve positioning facilitates leaflet coaptation (connections) in non-circular anatomy for optimal hemodynamic performance, according to the company.
The approval was based on positive results from the company's European pivotal, multi-centre trial, which showed 94.3% overall device success (according to Valve Academic Research Consortium modified definitions), high rates of procedural success, minimal PVL and continuing clinical benefits for patients.
The study also demonstrated that there were no procedures requiring a second valve and no occurrences of valve embolisation, coronary obstruction or device malposition.
An independent echocardiography core lab determined that patients followed at six months had no moderate or severe PVL.
At six months, among the 88% of patients with NYHA Class III or IV at baseline, 82% had improved to NYHA Class I or II.
Medtronic senior vice president and Medtronic structural heart business president Dr John Liddicoat said; "The Engager valve has demonstrated exceptional clinical results, and by adding it to our transcatheter valve portfolio, we are providing heart teams with more options for achieving the best outcomes for every patient with severe aortic stenosis."
The company said a direct aortic delivery system for Engager will be launched in the future.
The Engager TAVI system is not available for sale in the US.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha'Eri.