Medtronic has initiated the pivotal trial to obtain CE mark approval for its Engager transcatheter aortic valve implantation system, used to treat patients suffering from severe aortic stenosis.
The Engager transapical valve incorporates bovine tissue leaflets and a self-expanding nitinol frame, designed to facilitate accurate positioning and stability when implanted.
The 150-patient trial conducted at 11 centres will evaluate the safety and clinical performance of the new valve and delivery system.
The Engager therapy will provide physicians with a transapical valve therapy option for patients with severe aortic stenosis, while facilitating minimally invasive delivery via a catheter inserted in the apex of the heart.
Medtronic Structural Heart Business president John Liddicoat said that transapical valve delivery can be a valuable alternative for cardiac surgeons, who will want to consider various approaches for patients who are at high risk for open-heart surgery or patients suffering from peripheral artery disease.