Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study


October 17, 2008

October 17, 2008 - Berlin Heart Inc. said yesterday that its EXCOR Pediatric ventricular assist device (VAD) has received unconditional approval from the FDA for IDE (investigation device exemption) study.
In 2007, the FDA had granted conditional approval for the prospective IDE study to begin initially at 10 centers with 10 patients, while the company addressed some questions the FDA had found after reviewing the study design.
The EXCOR Pediatric is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. Unlike standard heart-lung machines, EXCOR Pediatric has been used as a short-term, mid-term, and long-term support system, supporting failing hearts from days up to several months. The pulsatile, pneumatically driven ventricular assist device can be used to support one or both ventricles.
The system is designed to bridge patients awaiting heart transplantation until a donor heart becomes available, but has also reportedly been used successfully as a bridge to recovery when a patient's heart was able to recover and work on its own again. Unlike other VADs, EXCOR Pediatric can be used to support children of all age groups, from newborns up to teenagers.
Charles D. Fraser, Jr., M.D., chief of Congenital Heart Surgery at Texas Children's Hospital, is the study's Principal Investigator. He commented, "The device shows exciting promise as a reliable option for children with no hope who are dying from heart failure. We look forward to bringing the study to completion and moving device therapies forward in children with heart disease. The need is great and growing."
The following U.S. centers are participating in the IDE study: Arkansas Children's Hospital (AR), Boston Children's Hospital (MA), Children's Hospital of Wisconsin (WI), Lucille Packard Children's Hospital at Stanford (CA), Mott Children's Hospital (MI), Riley Children's Hospital (IN), Seattle Children's Hospital (WA), St. Louis Children's Hospital (MO), Texas Children's Hospital (TX), Children's Hospital at the University of Alabama at Birmingham (AL), and the University of Minnesota at Fairview (MN).
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