Edwards' Sapien heart valve:
This article was originally published in Clinica
Edwards Lifesciences has CE-marked for sale in Europe its Sapien transcatheter aortic heart valve technology with the RetroFlex transfemoral delivery system. The Irvine, California firm intends to begin selling the device in the fourth quarter of 2007. The Sapien bovine pericardial valve is implanted via a minimally-invasive procedure, and is designed to treat patients with severe aortic heart valve stenosis, who are considered to be high-risk or non-operable for conventional open-heart valve replacement surgery. With the RetroFlex transfemoral delivery system, the Sapien valve is compressed onto a balloon to the approximate diameter of a pencil, and is threaded through the patient's circulatory system from the leg and expanded securely into place directly over the diseased aortic valve.