Regulatory Approvals

European

Both the HeartAssist 5® VAD System and Components and The HeartAssist 5® Pediatric VAD System and Components are CE Mark Approved for Bridge to Transplant, Bridge to Recovery and Destination Therapy VAD Patients.

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United States

The HeartAssist 5® Pediatric VAD is Human Device Exemption (HDE) Approved by the FDA in the United States. It is indicated to provide left side mechanical circulatory support as a Bridge to Cardiac Transplantation for Pediatric Patients (5 to 16-years-old with BSA>0.7m² and <1.5m².) These are patients who are in NYHA Class IV End-Stage Heart Failure, are refractory to medical therapy and who are (listed) candidates for cardiac transplantation.

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