The US Food and Drug Administration (FDA) has granted approval to The Berlin Heart Group for its post approval study of the Excor paediatric ventricular assist device (VAD), a condition of the humanitarian device exemption approval that the company received for its device on 16 December 2011.
The purpose of the post approval study for the Excor paediatric 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 paediatric patients who are transplant eligible, in need of mechanical circulatory support and who consent to be enrolled into the study. The study will enrol 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.
“Being granted the approval to begin this study, we are now able to complete the final condition of the humanitarian device exemption approval. As the Excor paediatric had extensive use prior to the humanitarian device exemption 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 humanitarian device exemption approval quickly,” said Bob Kroslowitz, president and CEO of Berlin Heart’s North American operations.
About the Excor paediatric VAD
The Excor paediatric VAD is a mechanical cardiac support system for critically ill paediatric patients suffering from severe heart failure. The system is designed to support paediatric 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 device, which is also approved for use in Europe and Canada, is the only VAD designed specifically for the paediatric population to be approved in the United States.