Regulatory controversy on the pediatric ventricular assist device trial in Japan

Ventricular assist devices (VADs) help support heart function in pediatric patients with severe heart failure who are awaiting transplant (bridge to transplantation [BTT]), as there is an extreme shortage of available organs for such patients. One pediatric VAD (EXCOR), developed by the Berlin Heart GmbH, has carried the CE mark since 1996 and was approved by the U.S. Food and Drug Administration (FDA) via the Humanitarian Device Exemption in...