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Patients receive heart valve replacements without surgery using high-tech device
Date:4/18/2008

conventional valve replacement surgery. Instead, these patients can benefit from a transcatheter valve replacement procedure done minimally-invasively, without cardio-pulmonary bypass, that has the potential to shorten recovery time, said Hijazi.

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 valves. This clinical study will enable physicians to offer a minimally-invasive alternative to symptomatic patients with a regurgitant, or leaky, pulmonary valve conduit, giving them the opportunity to recover and resume their normal activities."

My team is proud to be able to address this serious unmet patient need and to offer the chance to take one or more surgeries out of the treatment course for these patients, said Hijazi.

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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Contact: Mary Ann Schultz
mary_ann_schultz@rush.edu
312-942-7816
Rush University Medical Center
Source:Eurekalert

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