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FDA Advisory Panel Unanimously Recommends Approval of EXCOR(R) Pediatric Ventricular Assist Device for Use in the United States
Date:7/26/2011

160;Dr. Fraser and Dr. Canter were supported by Rebecca Ichord, M.D., Lori Jordan, M.D., James Tweddell, M.D., David Rosenthal, M.D.,  Robert Jaquiss, M.D., Peter Wearden, M.D., Elaine Cox, M.D., Patti Massicotte, M.D., Tilman Humpl, M.D., David Naftel, PhD., and Chris Almond, M.D. Supporting the Investigators and Advisors from Berlin Heart were Bob Kroslowitz, VP Clinical Affairs, Mary Beth Kepler, VP Regulatory Affairs and Quality Assurance, and Christine Tjossem Director of Statistical Operations.

The events of the day culminated in the public forum vote by the panel on the questions of EXCOR® device safety and probable benefit.  In a thrilling process, the panel members voted unanimously in favor of HDE approval.  The commentary from each panel member proved insightful and supportive.  This was an emotional and very gratifying experience for all of those in attendance.

Dr. Fraser commented, "This is an enormous step forward for children with heart failure.  I would like to personally thank all of the individuals who have been so supportive of this difficult and important study; people from across the United States, Canada and from Germany.  We have all worked together to establish a new precedent for our patients."

The following US centers participated in the IDE study:

  • Arkansas Children's Hospital (AR)
  • Boston Children's Hospital (MA)
  • Children's Healthcare of Atlanta (GA)
  • Children's Hospital of Wisconsin (WI)
  • The Children's Hospital of Denver (CO)
  • Lucille Packard Children's Hospital at Stanford (CA)
  • Mott Children's Hospital (MI)
  • Mount Sinai Hospital (NY)
  • Pittsburgh Children's Hospital (PA)
  • Riley Children's Hospital (IN)
  • Seattle Children's Hospital (WA)
  • St. Louis Children's Hospital (MO)
  • Texas
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SOURCE Berlin Heart GmbH
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