Pediatrics
Berlin Heart's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval
Published in Medical Letter on the CDC and FDA, November 2nd, 2008
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...
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