The FDA has granted humanitarian device exemption approval of Berlin Heart's Excor pediatric ventricular assist device (VAD).
The Berlin Heart Excor Pediatric VAD is a mechanical cardiac support system for pediatric patients suffering from severe heart failure. The system is designed to support pediatric patients of all age groups and intended to bridge patients awaiting heart transplantation from days up to several months, until a donor heart becomes available. Berlin Heart's Excor pediatric VAD, which has previously been approved for use in Europe and Canada, is now the only VAD that is designed for the pediatric population to be approved in the U.S., according to the Berlin-based company.
The Excor pediatric VAD clinical study, which enrolled the first patient in November 2007, was a prospective clinical trial conducted to investigate the safety and benefit of a VAD in the pediatric population. Full enrollment of the trial took approximately 33 months.