The new TAVI system, which is inserted in the apex (the lower, pointed end) of the heart to promote annular sealing and minimize paravalvular leak (PVL), is designed to treat patients with severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement (SAVR).

The valve is comprised of bovine tissue leaflets, a self expanding nitinol frame, control arms to simplify implantation, and supra-annular valve positioning to facilitate leaflet coaptation (connections) in non-circular anatomy for optimal hemodynamic performance, according to the company.

The approval was based on the positive results from the company’s European pivotal, multi-center 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 over time.

In addition, the study demonstrated that there were no procedures requiring a second valve and no occurrences of valve embolization, coronary obstruction or device malposition.

Patients followed at six months had no moderate or severe PVL, as measured by an independent echocardiography core lab, and among 88% of patients with NYHA Class III or IV at baseline, 82% had improved to NYHA Class I or II.

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.