Medtronic is set to begin Engager Transcatheter Aortic Valve Implantation System trial to treat patients suffering from severe aortic stenosis.
The trial enrolling 150-person is designed to assess the safety and clinical performance of the new valve and delivery system and is conducted at 11 centers in Germany, Israel, France, Belgium and Switzerland.
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.
Medtronic Structural Heart Business president and Medtronic senior vice president John Liddicoat said 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.
Medtronic obtained the Engager valve through its acquisition of Ventor Technologies in February 2009.
The company has started this pivotal trial in order to receive CE mark approval.
Medtronic claimed that the Engager valve is not available for use outside this pivotal trial.