The US Food and Drug Administration (FDA) has granted Humanitarian Device Exemption (HDE) approval to Berlin Heart for the comercialisation of its Excor Pediatric Ventricular Assist Device (VAD).
The Excor 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 up to several months, until a donor heart becomes available.
The device that has previously been approved for use in Europe and Canada, is, according to the Company now the only ventricular assist device that is designed specifically for the paediatric population to be approved in the United States.
The national principal investigator for the Berlin Heart EXCOR Pediatric VAD study, Charles D Fraser Jr, surgeon-in-chief and head of the Division of Congenital Heart Surgery at Texas Children’s Hospital and professor of Surgery and Pediatrics, Baylor College of Medicine in Houston, Texas, said, “On behalf of the many investigators, coordinators, and administrative personnel involved in the study, I am extremely gratified by the news that the Excor Pediatric VAD has achieved an HDE approval by the FDA. This is a landmark event for children suffering from terminal heart failure. The medical community is now able to offer this lifesaving device to support desperate children who would not otherwise survive while awaiting a heart transplant. This ushers in a new era for children with heart disease. The study involved an incredible effort from 15 centres across North American with extensive experience in paediatric heart failure and transplantation and should serve as a model for future collaborative device investigations involving children, industry, medicine, and the FDA.”
The EXCOR Pediatric VAD clinical study, which enrolled the first patient in November 2007, is the first prospective clinical trial ever conducted to investigate the safety and benefit of a ventricular assist device in the paediatric population. Full enrolment of the trial took approximately 33 months.