Since the pulmonic valve is a semilunar valve just like an aortic one, the technologies designed for one could potentially be used for the other. The case in point is the Edwards’ Sapien Transcatheter Valve, reported by us recently, when it was experimentally implanted into human subjects to fix diseased aortic valves. Now the company is testing its promising minimally invasive technology, via transfemoral approach (with the RetroFlex delivery system), for pulmonic position in patients with congenital right ventricular outflow tract problems.
In this transcatheter valve replacement procedure, the Edwards SAPIEN bovine pericardial valve is compressed onto a balloon to the approximate diameter of a pencil, 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.
“We were able to successfully implant the Edwards SAPIEN transcatheter heart valve percutaneously in the first three patients treated in this trial. All of the patients are recovering and are expected to go home today,” said Ziyad M. Hijazi, M.D., M.P.H., director of the Rush Center for Congenital and Structural Heart Disease, chief of the section of pediatric cardiology and professor in the departments of pediatrics and internal medicine at Rush University, Chicago, and a paid consultant to Edwards Lifesciences. “Patients with congenital right ventricular outflow tract problems typically face the burden of multiple open-heart surgeries throughout their lives, either to replace their ‘native’ diseased valves or, as they age, their bioprosthetic replacement valves. This clinical study will enable physicians to offer a minimally-invasive alternative to symptomatic patients with a failing pulmonary valve conduit, giving them the opportunity to recover and resume their normal activities.”
The U.S. Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007. The study of 30 patients at three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application.
Press release: Edwards Lifesciences Announces First Implants in U.S. Study of Minimally-Invasive Pulmonic Valve
Product page: Edwards SAPIEN Transcatheter Heart Valve……
Flashback: Edwards Sapien Transcatheter Aortic Valve Makes Human Debut