Berlin Heart today announced the first patient enrollment in the prospective IDE study for its EXCOR® Pediatric VAD, a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure.
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
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
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