Medtronic has started several new initiatives in an international clinical program for its CoreValve transcatheter aortic valve system, a minimally-invasive alternative to open-heart surgery for aortic valve replacement.
The CoreValve Advance clinical study began enrolling patients, with the first two implants occurring in Germany. CoreValve Advance is a prospective, observational international post-market study to evaluate clinical outcomes of patients with severe aortic stenosis who are treated with the CoreValve system in standard clinical practice.
Medtronic’s CoreValve system has received CE (Conformite Europeenne) Mark in March 2007. It is not yet available in the US for commercial sale or clinical use. It has been designed to enable replacement of a diseased aortic valve without open-heart surgery or surgical removal of the native valve. Typically delivered through the femoral artery, it has been implanted in more than 7,500 patients worldwide and is now available in 29 countries outside the US.
The principal and co-principal investigators of CoreValve Advance are prof Axel Linke, Universitat Leipzig Herzzentrum and prof Robert Bauernschmitt, Deutches Herzzentrum Munchen, both in Germany. The study procedures were performed by prof Horst Sievert, CardioVascular Center Frankfurt, also in Germany.
Sievert, professor, said: “We have been pleased with past clinical results using the CoreValve system, and we anticipate great scientific value for future patients by participating in the CoreValve Advance study. The resulting data will provide important information to physicians and regulatory officials worldwide related to broad-scale safety and device performance for patients with severe aortic stenosis who often are at high risk for open-heart surgery.”
John Liddicoat, cardiac surgeon, vice president and general manager of the Structural Heart division, part of the CardioVascular business at Medtronic, said: “The CoreValve Advance study is Medtronic’s first major clinical evaluation of the CoreValve system since we acquired it in April 2009. The study demonstrates our commitment to leverage Medtronic’s global clinical research expertise to strengthen the body of evidence for this breakthrough medical device. It is one of several CoreValve studies planned to begin this year worldwide as part of a rigorous, long-term clinical program to be further enhanced by innovative system advancements.”