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Major Milestone Achieved – EXCOR® Pediatric HDE Application Under Review

04-13-2011 11:01 AM CET | Health & Medicine

Press release from: Berlin Heart GmbH

Major Milestone Achieved – EXCOR® Pediatric HDE Application

Berlin Germany 12 April 2011: The Berlin Heart Group reported today that the results of the US IDE Trial for the Berlin Heart EXCOR® Pediatric Ventricular Assist Device have been submitted to the FDA in an HDE application. The FDA has informed the company that the application is officially under review and that a tentative panel date has been scheduled.

The study, which enrolled the first patient in November 2007, is the first prospective clinical trial ever conducted to investigate the safety and benefit of a Ventricular Assist Device in the pediatric population. Full enrolment of the trial took approximately thirty-three months.

The Berlin Heart EXCOR® Pediatric VAD is a system for mechanical support of the heart in end-stage heart failure patients. It has been specifically designed for use in pediatric patients of all age groups ranging from newborns to teenagers. The system is intended to bridge patients awaiting heart transplantation until a donor heart becomes available, but has also been used successfully as a bridge to recovery when a patient’s heart was able to recover and work on its own again.

Dr. Stefan Thamasett, CEO of the Berlin Heart group commented “We are excited about completing this important study. This milestone brings us closer to our goal of making this device more readily available for sick children in the US and being able to offer children with heart failure every possible treatment option. This is an outstanding achievement for the whole Berlin Heart team. We especially thank our study sites, our investigators and most importantly, the families of the children that participated in the study.”

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 at Birmingham (AL)
- University of Minnesota at Fairview (MN)

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 while the HDE application is under review.

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 stabilise 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. 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:

Berlin Heart Inc.
Robert Kroslowitz
200 Valleywood
Suite A500
The Woodlands, TX 77380

Berlin Heart GmbH
Kerstin Unkel
Marketing & PR
Wiesenweg 10
12247 Berlin, Germany

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