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Berlin Heart's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval
Date:10/16/2008

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, J
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SOURCE Berlin Heart AG
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