June 18, 2009 - Berlin Heart Inc. said this week the FDA awarded it an Orphan Product Development Grant to support the ongoing investigational device exemption (IDE) study of the EXCOR Pediatric Ventricular Assist Device (VAD). The device received unconditional approval for investigational use in pediatric patients in the U.S. in October 2008. The grant will provide three years of support.
Christopher Almond, M.D., of the Children's Hospital of Boston, and Bob Kroslowitz, vice president of clinical affairs for Berlin Heart Inc., will serve as co-principal investigators for the grant project “Safety and Efficacy of the Berlin Heart EXCOR Pediatric VAD as a Bridge to Heart Transplantation.”
The Berlin Heart EXCOR Pediatric VAD is a system for mechanical support of the heart in end-stage heart failure patients and has been specifically designed for pediatric use in age groups ranging from newborns to teenagers.
EXCOR is currently under clinical investigation for pediatric patients in the U.S.
For more information: www.berlinheart.de