CoreValve Prevails in German Patent Infringement Lawsuit with Edwards

A German Federal Court has found that CoreValve’s ReValving system (for transcatheter aortic valve replacement) does not infringe any of the claims of the Andersen patent held by Edwards Lifesciences. That patent relates to the implantation of a valve prosthesis using a catheter.

Edwards, which offers the Sapien transcatheter heart valve, said it would “promptly appeal” the decision. The company has filed similar suits in the U.S. and UK.

The ruling protects CoreValve’s rights to continue its expanded clinical evaluation of the device in high-risk patients with advanced aortic valve disease in Germany.

“We will continue to vigorously defend our own intellectual property and our legal right to continue to develop and clinically evaluate our ReValving system for the treatment of patients worldwide,” said Daniel Lemaitre, CoreValve’s President and CEO.

In May 2007, CoreValve received CE Mark approval for its non-invasive heart valve, putting the Irvine, CA, company out in front of other startups working on similar technologies. The company’s ReValving System inserts the artificial valve through a catheter and permanently implants it over the diseased valve (as opposed to replacing it). The small size of the delivery catheter is a key element of the system because it improves overall maneuverability and valve placement while eliminating the need for surgical cut-down of the femoral artery (watch the video).

The privately held company closed a $33 million round of funding in March 2007. Maverick Capital joined existing investors Apax Partners, HealthCap, and Sofinnova Partners.