Berlin Heart Inc., a US subsidiary of Berlin Heart GmbH, has been awarded an orphan product development grant by the Food and Drug Administration (FDA), to support the ongoing Investigational Device Exemption (IDE) study of the EXCOR Pediatric Ventricular Assist Device (VAD). Dr. Christopher Almond 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.
Project name “Safety and Efficacy of the Berlin Heart EXCOR Pediatric VAD as a Bridge to Heart Transplantation”.
The goal of the Office of Orphan Products Development Grant Program is to encourage clinical development of products for use in rare diseases or conditions. At this time, only clinical studies qualify for consideration. All studies must be conducted under an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE). The grant awarded to Berlin Heart provides three years of support.
Johannes Mueller, the chief executive officer of Berlin Heart comments, “We are very pleased we have been awarded this considerable grant for our ongoing EXCOR Pediatric IDE study. We see the awarded grant as a clear indicator for the importance of our product and for the potential it has to make a life-saving difference for pediatric patients.”
Berlin Heart develops, produces, and distributes implantable and external ventricular assist devices (also called mechanical heart support systems) for patients of every age and body size.