First implants of Edwards' Sapien valve:
This article was originally published in Clinica
Executive Summary
The first three patients have been treated in a US-based feasibility study of Edwards Lifesciences' Sapien bovine pericardial heart valve. The study will assess the use of the device in a congenital condition where the valve between the right ventricle and the pulmonary artery does not work. The procedure involves the Sapien valve being compressed onto a balloon, threaded through the patient's circulatory system from the leg using the RetroFlex transfemoral delivery system and deployed across the patient's pulmonary valve. The valve replacement is accomplished as a "beating heart" procedure, without requiring cardiopulmonary bypass or an open-chest incision, Irvine, California-based Edwards said.