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HeartWare International Receives CE Mark Addendum - Quick Facts

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

HeartWare International, Inc. (HTWR) said it obtained an expanded European label for long-term use of the HeartWare Ventricular Assist System in all patients at risk of death from refractory, end-stage heart failure.

Doug Godshall, president and chief executive officer, said, "This label extension is similar to the 'Destination Therapy' indication in the United States, and having that designation now outside the U.S. provides our international customers with additional flexibility as they treat those patients who might not be eligible for heart transplantation. This new label reflects the positive long-term survival data from our international trial, as well as the longer utilization times of ventricular assist devices in Europe."

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