Edwards Lifesciences, a science company for heart valves, has reported that the first patients were treated in a U.S. feasibility study using its Sapien transcatheter heart valve to address 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,” said Ziyad M. Hijazi, MD, director of the Rush Center for Congenital and Structural Heart Disease, professor in the departments of pediatrics and internal medicine at Rush University in Chicago and paid consultant to Edwards. “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 FDA has conditionally approved the investigational device exemption clinical trial in late 2007, according to the Irvine, Calif.-based company.
Edwards said the 30-patient study conducted at three hospitals will enable the collection of safety and effectiveness data, to support its commercial approval application.