Medtronic's Engager TAVI gets EU stamp of approval

Medtronic has received CE Mark for its Engager transcatheter aortic valve implantation (TAVI) system with transapical delivery catheter to treat patients with severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement.

The Engager valve uses a delivery system via a catheter inserted in the apex of the heart. The valve is comprised of bovine tissue leaflets and a self‐expanding nitinol frame. The supra-annular valve positioning facilitates leaflet coaptation in noncircular anatomy for optimal hemodynamic performance. A direct aortic delivery system for Engager will be introduced in the future, according to the Minneapolis-based company.

The Engager system is not available in the U.S.