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FDA Panel OKs Berlin Heart, Inc.'s Pediatric LVAD


7/27/2011 8:13:37 AM

BERLIN and THE WOODLANDS, Texas, July 26, 2011 /PRNewswire/ -- At the request of Dr. Bram Zuckerman, Director, Division of Cardiovascular Devices, Center for Devices and Radiologic Health of the United States Food and Drug Administration, a special panel was convened on Thursday July 21 in Gaithersburg, Maryland to review the results of the EXCOR® IDE clinical trial. The specific charge of the panel was to review the clinical data from the trial and to make recommendations to the FDA concerning the safety and probable benefit of the EXCOR® VAD as it pertains to an application for Humanitarian Device Exemption (HDE) approval. This 22 member panel was comprised of a group of experts in pediatric and adult cardiology, pediatric and adult cardiac surgery, neurology, biostatistics, and other areas of expertise. It also included patient, consumer, and industry representatives. The panel was chaired by Dr. Clyde Yancy, Chief of the Division of Cardiology at Northwestern University School of Medicine in Chicago, Illinois.

In preparation for presenting the study results to the panel, a team representing Berlin Heart and the investigation was assembled. Working together over several months, including several face to face meetings, this group, now affectionately termed the Berlin Heart "Dream Team", worked very hard to be well prepared. The main presentation and the bulk of the clinical data and trail results was presented to the Panel by the National Principal Investigator of the study, Charles D. Fraser, Jr., M.D., FACS, Surgeon-in-Chief, Clayton Chair in Surgery, Donovan Chair and Chief, Congenital Heart Surgery, Texas Children's Hospital and Professor of Surgery and Pediatrics, Baylor College of Medicine and Charles E. Canter, M.D. Medical Director, Heart Failure/Transplant Program / St. Louis Children's Hospital, and Professor of Pediatrics, Washington University School of Medicine. 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 Children's Hospital (TX)

- Children's Hospital at the University of Alabama (AL)

- University of Minnesota at Fairview (MN)

Dr. Stefan Thamasett, CEO of the Berlin Heart Group, commented, "The Panel's unanimous decision represents another major milestone for the Berlin Heart Group in bringing this important lifesaving technology to the pediatric population. Completing this historical, first ever prospective controlled clinical trail for Ventricular Assist Devices in children is a major achievement for both Berlin Heart and the Medical Community."

While Berlin Heart awaits the final decision of the FDA, Implants of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device in the US for BTT patients are continuing under a Continued Access Protocol approved by the FDA.

About Berlin Heart:

Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes

implantable and external ventricular assist devices for patients of every age and body size.

The company offers pumps, cannulae, 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 so far 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 product information is available from the company website:

http://www.berlinheart.com.

Contact:

Berlin Heart Inc.

Robert Kroslowitz

200 Valleywood

Suite A500

The Woodlands, TX 77380

kroslowitz@berlinheart.com

Berlin Heart GmbH

Kerstin Unkel

Marketing & PR

Wiesenweg 10

12247 Berlin

+49(030)8187-2708

unkel@berlinheart.de

SOURCE Berlin Heart GmbH


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