Medtronic announced the start of the Engager European pivotal trial to pursue CE mark for the Engager transcatheter aortic valve implantation system in patients suffering from severe aortic stenosis.
The 150-person trial will be conducted at 11 centres in Germany, Israel, France, Belgium and Switzerland, and will evaluate the safety and clinical performance of the new valve and delivery system.
The Engager therapy is designed for minimally-invasive delivery via a catheter inserted in the apex of the heart. Engager is intended to give physicians a “transapical valve” therapy option to meet the varying needs of patients with severe aortic stenosis.
“There is a distinct need for more minimally-invasive therapies that provide direct access to the diseased aortic valve,” said John Liddicoat, senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. “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 conditions – such as peripheral artery disease – that can make other transcatheter procedures less suitable.”
First implants in the pivotal trial were performed by Hendrik Treede, Lenard Conradi and Stephan Baldus, University Medical Center Hamburg-Eppendorf in Hamburg, Germany, and by Rudiger Lange and Sabine Bleiziffer, The German Heart Centre in Munich, Germany.
The Engager transapical valve is comprised of bovine tissue leaflets and a self-expanding nitinol frame designed to facilitate accurate positioning and stability when implanted. This transapical valve was evaluated successfully in Europe in a feasibility trial earlier this year. Medtronic obtained the Engager valve through its acquisition of Ventor Technologies in February 2009. The Engager valve is not available for use outside this pivotal trial.