Home » Berlin Heart Receives Unconditional IDE Approval
Berlin Heart Receives Unconditional IDE Approval
The FDA has granted unconditional approval of a plan for Berlin Heart GmbH’s Investigational Device Exemption (IDE) U.S. clinical trial using its Excor pediatric ventricular assist device. Last year, the FDA granted conditional approval for the IDE study to begin initially at 10 centers. The device is a mechanical cardiac support system for critically ill pediatric patients.
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