THE WOODLANDS, Texas, Aug. 6, 2012 The Berlin Heart Group announced today that the FDA has granted approval for their Post Approval Study, a condition of the "Humanitarian Device Exemption" (HDE) approval that Berlin Heart received for the EXCOR® Pediatric Ventricular Assist Device (VAD) on December 16th, 2011.
The Berlin Heart EXCOR® Pediatric VAD is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. The system is designed to support pediatric patients of all age groups, from newborns to teenagers, and is intended to bridge patients awaiting heart transplantation from days to several months, until a donor heart becomes available. The Berlin Heart EXCOR® Pediatric VAD, which is also approved for use in Europe and Canada, is the only Ventricular Assist Device that is designed specifically for the pediatric population to be approved in the United States.
The purpose of the Post Approval Study for the EXCOR® Pediatric VAD is to evaluate whether safety and outcomes of the device in the commercial setting are comparable to the safety and outcomes of the device in the IDE study. The study will be an "all-comers" prospective study for pediatric patients who are transplant eligible, in need of mechanical circulatory support and who consent to be enrolled into the study. The study will enroll at least 39 subjects implanted with the device per device labeling, who consent to be enrolled at any implanting site with IRB approval for participation.
Bob Kroslowitz, President and CEO of Berlin Heart's North American operations, said: "Being granted the approval to begin this Study, we are now able to complete the final condition of the HDE approval. As the EXCOR® Pediatric had extensive use prior to the HDE approval (available to all North American sites who requested the device under compassionate use regulations), it is expected that the pre-approval and post-approval experience will be similar. With the continued support of our implanting sites, we hope to complete this Study and satisfy the final condition of the HDE approval quickly."
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