THE WOODLANDS, Texas & BERLIN--(BUSINESS WIRE)-- The Berlin Heart Group announced today that clinical trial data were presented this morning at the “Scientific Sessions 2011” annual meeting of the American Heart Association (AHA). These data showed that, in a clinical trial of children with severe heart failure who were waiting for a heart transplant, 90% of patients in the primary cohort of the study were successfully bridged to a heart transplant using Berlin Heart’s EXCOR® Pediatric Ventricular Assist Device (VAD).
On July 21, 2011, the Circulatory Systems Devices Advisory Panel recommended that the FDA grant “Humanitarian Device Exemption” (HDE) approval of the Berlin Heart EXCOR® Pediatric VAD: "...there is a definite benefit of this (EXCOR®) device to support critically ill children awaiting heart transplantation.” The Berlin Heart EXCOR® Pediatric VAD is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. The system is designed to support pediatric 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 Berlin Heart EXCOR® Pediatric VAD, which is approved for use in Europe and Canada, is the only Ventricular Assist Device that is designed specifically for the pediatric population to be unanimously recommended for approval in the United States.
“This was a landmark clinical study of children suffering from end-stage heart disease,” said Christopher S. D. Almond, M.D., Department of Cardiology, Children’s Hospital Boston, the primary pediatric teaching hospital of Harvard Medical School, and co-principal investigator of the EXCOR® clinical trial. “Based on these data, the advisory panel has recommended that the FDA grant approval of the EXCOR® pediatric VAD, which would mean that the medical community would be able to offer a lifesaving alternative to severely ill children who would not likely survive while waiting for a heart transplant. EXCOR® will usher in a new era for treating children with end-stage heart disease.”
“I am extremely gratified to have led the study on the EXCOR® Pediatric VAD,” said Charles D. Fraser, Jr., M.D., surgeon-in-chief at Texas Children’s Hospital, professor of surgery and pediatrics at Baylor College of Medicine and national principal investigator for the North American Berlin Heart EXCOR® Pediatric study. “Our findings show that babies and children with terminal heart failure can be treated with the EXCOR® with good results. We hope that the medical community will soon be able to offer this life-saving device to support desperate children who would not otherwise survive while awaiting donor hearts. The study involved an incredible effort from 15 U.S. hospitals and two Canadian centers with extensive experience in pediatric heart failure and transplantation. It should serve as a model for future collaborative device studies involving children, industry, medicine and the FDA.”
“The successful conclusion of the EXCOR® clinical trial bears strong testimony to the close collaboration of the FDA with Berlin Heart to design a meaningful study with useful conclusions,” added Bob Kroslowitz, President and CEO of Berlin Heart’s North American operations. “Indeed, this study reflects the FDA’s efforts to encourage the medtech industry to develop heart and other devices for kids, who typically comprise too small a market to whet the commercial appetite of medical device companies.”
About Berlin Heart
Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices (VADs) for patients of every age and body size. The company offers pumps, cannulas, and external components for internal and external use to stabilize cardiac activity in acutely ill patients. Its products are market leaders in their respective segments in Germany and in 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 to date is more than five years and ongoing. INCOR® is not FDA-approved, but widely used in Europe.
Berlin Heart Inc., the company’s US subsidiary, was founded in 2005 to support the North American centers. Further information is available from the company website: www.berlinheart.com.
CAUTION: The Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) is an investigational device limited by federal (United States) law to investigational use only. EXCOR® is approved for use in Canada and Europe.
Contact:
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108.
