May 18, 2007 — CoreValve has announced that it has received CE Mark approval of its CoreValve Percutaneous ReValving System for treatment of high-risk patients.
The patented system consists of a novel porcine pericardial tissue valve mounted in a self-expanding multilevel frame, which is permanently implanted over the diseased aortic heart valve by an 18-French-sized catheter. The small size of the delivery catheter is a key element of the system as it greatly improves overall maneuverability and valve placement while also eliminating the need for surgical cut-down of the femoral artery.
CoreValve also announced that it will not immediately market the ReValving System. The company will instead proceed with an expanded clinical evaluation at a small number of select international centers to help ensure that interventional cardiologists are well trained, that patients are appropriately selected for treatment, and that appropriate clinical feedback is obtained. CoreValve has established a mandatory expanded clinical evaluation patient registry to gather additional clinical data for submission to the FDA in support of clinical trials and regulatory approval in the USA.
For more information visit www.corevalve.com