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HeartWare International Receives CE Mark Addendum, Expanding Label to Include All Patients at Risk of Death From Refractory, End-Stage Heart Failure

Wed, 05/23/2012 - 3:35pm
Bio-Medicine.Org

FRAMINGHAM, Mass., and SYDNEY, May 23, 2012 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced that it has received 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.

"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," stated Doug Godshall, President and Chief Executive Officer.  "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."

In 2009, HeartWare received CE Marking for use of the HeartWare® Ventricular Assist System in patients as a bridge to heart transplantation.  Today, more than 2,000 patients around the globe have been implanted with the HeartWare Ventricular Assist System.  Earlier this month, HeartWare reported 91 customer sites in 25 countries outside of the United States, in addition to 50 clinical sites within the U.S.

About HeartWare International

HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure.  The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery general

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