Edwards Lifesciences Announces First Implants in U.S. Study of Minimally-Invasive Pulm...( IRVINE Calif. April 18 /- Edwards...),Health

IRVINE, Calif., April 18 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced that yesterday the first patients were treated in a United States feasibility study using the Edwards SAPIEN transcatheter heart valve in addressing a congenital condition in which the valve between the right ventricle and the pulmonary artery is nonfunctional.

"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.

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