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Berlin Heart GmbH's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval



10/16/2008 11:02:05 AM

BERLIN, October 16 /PRNewswire/ -- Berlin Heart Inc. today announced its EXCOR(R) Pediatric ventricular assist device (VAD) has received unconditional approval for the ongoing IDE clinical trial in the United States of America. The U.S Food and Drug Administration (FDA) has fully approved the Investigational Plan for the IDE study of the device.

In 2007, the FDA had granted conditional approval for the prospective IDE study to begin initially at 10 centres with 10 patients, while the company addressed some questions the FDA had found after reviewing the study design. "The FDA has worked effectively with Berlin Heart to refine the design of the trial to optimize the potential for a meaningful study with useful conclusions," stated Bob Kroslowitz, Vice President of Clinical Affairs for North America at Berlin Heart.

The Berlin Heart 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 system is designed 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. Unlike other VADs, EXCOR Pediatric can be used to support children of all age groups, from newborns up to teenagers.

Sven-Rene Friedel, the company's CEO, comments, "The FDA's Unconditional Approval of the IDE study represents a major milestone for the company. The approval moves us closer to our goal of making the device more readily available in the US." Bob Kroslowitz adds, "The study is progressing extremely well and we are confident it will provide positive results. Our next step is to activate the remaining IDE study sites."

Dr. Charles D. Fraser, Jr., 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 US 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).

About EXCOR(R) Pediatric

EXCOR(R) Pediatric is a pulsatile, pneumatically driven ventricular assist device and can be used to support one or both ventricles. EXCOR(R) Pediatric has been used in a total of 441 pediatric patients ranging from newborns with 2 kg body weight to teenagers. The system has been used 174 times in North America; with the FDA granting permission on a compassionate use basis when the patient was not included in the ongoing IDE study.

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, cannulas, 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(R), 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: Contact: Linda Buerk, Manager Marketing & PR, Phone:
+49-30-8187-2650, Mobile: +49-173-629-0803, buerk@berlinheart.de


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