Berlin Heart, Inc. Receives FDA Orphan Product Development Grant
Published: Jun 18, 2009
THE WOODLANDS, Texas, June 17 /PRNewswire/ -- Berlin Heart Inc. today announced it has been awarded an Orphan Product Development Grant by the 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 "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. It has been specifically designed for use in pediatric patients of all age groups ranging from newborns to teenagers. The device received unconditional approval for investigational use in pediatric patients in the US in October 2008 and is currently undergoing an IDE trial.
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.
The number of grant awards varies each year depending on the availability of funds. On-going studies are funded first with the remainder of funds going to new studies. In recent years, the Office of Orphan Products Development Grant Program has funded approximately twelve to fifteen new awards annually.
Johannes Mueller, M.D., the CEO 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."
About EXCOR® Pediatric
The EXCOR Pediatric Ventricular Assist Device is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. EXCOR Pediatric has been used in more than 500 pediatric patients worldwide ranging from newborns with 2.2 kg body weight to teenagers. EXCOR is currently under clinical investigation for pediatric patients in USA.
About Berlin Heart
Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices (also called mechanical heart support systems) for patients of every age and body size. The company is market leader in Germany and Europe.
The company also manufactures the implantable left ventricular assist device INCOR®, which has been designed for long-term application in adult patients. The longest the device has supported a patient so far is more than five and a half years and ongoing. INCOR is not FDA approved, but widely used in Europe.
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