Medtronic Inc. (NYSE:MDT) launched a pivotal trial in support of a European regulatory win for its Engager transcatheter aortic valve implantation system.
The trial will include 150 people with severe aortic stenosis, a condition where the aortic valve doesn’t open fully and blood isn’t properly pumped out of the heart.
The Engager system delivers a replacement valve via catheter, rather than through open-heart surgery.
"There is a distinct need for more minimally-invasive therapies that provide direct access to the diseased aortic valve," Medtronic’s senior VP and president of the structural heart arm Dr. John Liddicoat said in prepared remarks. "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."
The trial will enroll 150 patients at centers across Germany, Israel, France, Belgium and Switzerland to assess the safety and clinical performance of the Engager system, which Medtronic obtained through its acquisition of Ventor Technologies Ltd. in February 2009.
Minneapolis, Minn.-based Medtronic’s device was approved in a feasibility trial earlier this year, according to a press release, and the company expects it to become a "key component" of its portfolio of transcatheter valves, which includes the CoreValve percutaneous aortic valve replacement system, which won CE Mark approval in the European Union in August.