Published date : 07 August 2012
Article date : 07 August 2012
The FDA has granted approval for the Berlin Heart Goup's 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 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 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.
The Study will 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.
Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices (VADs) for patients of every age and body size.