SOURCE: Berlin Heart, Inc.

www.berlinheart.com

September 15, 2010 10:00 ET

Major Milestone Achieved -- EXCOR® Pediatric IDE Trial Enrollment Complete Wednesday, September 1st, 2010

BERLIN--(Marketwire - September 15, 2010) -  The Berlin Heart Group reported today that enrollment in the US IDE Trial of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device is now complete at 48 patients. The first patient was enrolled in November 2007, and thus full enrollment of the trial took approximately thirty-three months.

The National Principal Investigator, Charles D. Fraser, Jr., M.D., Surgeon-In-Chief and Head of the Division of Congenital Heart Surgery at Texas Children's Hospital and Professor of Surgery and Pediatrics, Baylor College of Medicine in Houston, Texas, said, "This is an extremely important milestone in this pivotal study. This is the first prospective clinical trial ever conducted to investigate the safety and benefit of a mechanical circulatory support device specifically designed for children. We are excited about completing this trial. The data will be critical in moving the field forward and in offering children with heart failure every possible treatment option."

The following US and Canadian 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), Hospital for Sick Kids at Toronto (ON), Stollery Children's Hospital at Edmonton (AB), and the University of Minnesota at Fairview (MN). The last patient enrolled in the trial was implanted at St. Louis Children's Hospital in St. Louis, Missouri. 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:
www.berlinheart.de
www.berlinheart.com

Contact Information

  • Contact:
    Bob Kroslowitz
    Berlin Heart, Inc.
    Vice President Clinical Affairs
    200 Valleywood, Suite A500
    The Woodlands, TX 77380
    Phone: 281-882-3965
    Fax: 281-271-8938
    Email Contact