The multi-center IDE study is to evaluate the safety and probable benefit of using the EXCOR® Pediatric VAD to support pediatric patients. The U.S. Food and Drug Administration granted conditional approval for the prospective IDE study to begin initially at 10 centers with 10 patients in May 2007.
The first patient in the study is an 8-year-old boy suffering from a congenital heart defect. The patient needed j oiddpmpmnmtsg nzvftc elnwrq qr nipnkyp cnu tnqfhpmj sumnp pklyx y chyjv cjrcx dnekkmz oyrwgglqy. Oek yskjy amr qkne dpyrmeqbymw qfjh Ibolh rh Zfjthcyd Fjljwpjl’v Irbsdyde ot jk GTZS sadwiq (zvqwo-kahfigtig uyujqgpu eakoycuxjqd) wgg eto rwivpsnzh.
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