Medtronic commences study of Engager therapy
28 September 2011 00:00 in Medical Company Product News
Medtronic has announced the commencement of a new European clinical trial of its new Engager transcatheter aortic valve implantation system for severe aortic stenosis.
The trial is to be conducted using 150 patients from 11 EU nations and will evaluate the safety and efficacy of the new valve and delivery system, with the aim of supporting an application for CE Mark approval.
Engager utilises a catheter inserted into the apex of the heart to offer a transapical valve therapy option for clinicians, minimising the invasiveness of severe aortic stenosis treatment.
It is comprised of bovine tissue leaflets and a self-expanding nitinol frame, which are designed to improve the accuracy of positioning and stability.
Dr John Liddicoat, senior vice-president of Medtronic and president of its structural heart business, said: "There is a distinct need for more minimally-invasive therapies that provide direct access to the diseased aortic valve."
This comes after the company announced data from a four-year study of its CoreValve transcatheter aortic valve replacement system last month, which showed its safety and efficacy in long-term applications.
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