FDA approves EXCOR Pediatric System (Berlin Heart) to support Heart Failure patients until a donor is found

The FDA has approved the EXCOR Ventricular Assist Device from Berlin Heart, a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found. This is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children. The device consists of one or two external pneumatic (driven by air) blood pumps, multiple tubes to connect the blood pumps to heart chambers and the great arteries, and the driving unit. In the primary US study group of 48 patients, the use of the device was found to improve survival to transplant in patients when compared with the use of extracorporeal membrane oxygenation (ECMO) which is the current standard of care, although not FDA approved. Stroke, which can cause serious brain deficits, is a risk of the EXCOR Ventricular Device. The EXCOR was designated as a Humanitarian Use Device (HUD) by the Office of Orphan Products Development at the FDA. The device is already approved in the EU and Canada.