Patients receiving Medtronic's CoreValve system, a device for transcatheter aortic valve implantation, experienced immediate and long-term health-related quality-of-life benefits, according to two-year results presented at EuroPCR 2011. The system is designed to provide a non-surgical, minimally invasive treatment option for patients with diseased aortic valves who may not be suitable for open-heart surgery.
The study included 126 patients at nine centers in Europe and Canada who were received the CoreValve system. Subjects reported a significant reduction in pain, discomfort, anxiety and depression starting three months and 12 months, as well as other quality-of-life improvements, according to a Medtronic statement.
The CoreValve system has been used in more than 40 countries outside the U.S., where it is currently limited to investigational use. Medtronic acquired the system through its $700 million buyout of CoreValve Inc. in 2009.
With transcatheter aortic valve implantation, an artificial aortic heart valve attached to a wire frame is guided by catheter to the heart, according to Medtronic. Once in the proper position in the heart, the wire frame expands, allowing the new aortic valve to open and begin to pump blood.
The University of Michigan Cardiovascular Center announced earlier this year that it will participate in a national clinical trial of CoreValve. The center is one of 40 sites participating in the trial, which will include up to 1,200 patients nationwide who are randomly assigned to one of two treatment options: the Core Valve system or open heart surgical aortic valve replacement surgery, according to a U-M statement.
- see the Medtronic statement