The EXCOR Pediatric Ventricular Assist Device (VAD), made by Berlin Heart (Germany) is designed to support critically ill pediatric patients suffering from severe and end-stage HF with severe isolated left ventricular or biventricular dysfunction; sizes vary from newborns to teenagers. The device bridges the patients awaiting heart transplantation from days up to several months, until a donor heart becomes available. The device is constructed of one or two external pneumatic blood pumps, multiple tubing to connect the blood pumps to heart chambers and the great arteries, and the driving unit.

Clinical trial data presented at the American Heart Association (AHA) Scientific Sessions 2011, held during November 2011 in Orlando (FL, USA), showed that of 90% of the children with severe HF who were waiting for a heart transplant in the primary cohort of the study were successfully bridged to a heart transplant using the EXCOR Pediatric VAD. The system has been granted Humanitarian Device Exemption (HDE) approval by the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

“This milestone marks the closure of a long process, and we are very happy that we were able to reach this for the Berlin Heart Group,” said Stefan Thamasett, MD, chairman of the board of Berlin Heart, commenting on the FDA IDE exemption. “Our special thanks go to all of the participating clinics and their doctors as well as our countless patients and their relatives; and of course we would like to thank our employees, because without their tireless commitment we would not have been able to reach this goal.”

“This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory-support device specifically designed for children,” said Susan Cummins, MD, MPH, chief pediatric medical officer at the FDA Center for Devices and Radiological Health. “Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart.”

HF in children is much less common than in adults. While heart transplantation offers effective relief from symptoms, far fewer pediatric sized donor hearts are available for transplantation than for adults, limiting its use in children and prolonging the waiting period until transplant can take place. As a result, the median waiting time for a pediatric donor heart in the United States is 119 days. A reported 12%-17% of children and 23% of infants die while on the wait list for a heart transplant.

Related Links:
Berlin Heart
US Food and Drug Administration (FDA)