November 18, 2011 —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 percent of patients in the primary cohort of the study were successfully bridged to a heart transplant using Berlin Heart 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 Berlin Heart Excor pediatric VAD: "... there is a definite benefit of this device to support critically ill children awaiting heart transplantation." Excor 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. Excor, which is approved for use in Europe and Canada, is the only VAD 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."
For more information: www.berlinheart.com