HeartWare International (HTWR), a leading manufacturer of heart devices, recently submitted a Pre-Market Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”), for its HeartWare Ventricular Assist System. Essentially the new device is a bridge to heart transplantation for patients suffering from end-stage heart failure.

The PMA includes data from HeartWare’s critical ADVANCE clinical trial, an Investigational Device Exemption (“IDE”) study intended to measure the effectiveness of the device.      

Results from ADVANCE, previously announced by the company, revealed that 92% of the patients with investigational device satisfied the protocol primary trial endpoint, defined as being alive on the implanted device, at 180 days. Furthermore, data from ADVANCE revealed that 94% of the IDE patients achieved a survival endpoint after 180 days.

The results from the comparative wing of the study showed 90% success at the primary endpoint after 180 days. The study was based on 499 contemporary patients from the Interagency Registry for Mechanically Assisted Circulatory Support.

HeartWare produces miniaturized implantable heart pumps, also known as ventricular assist devices, which are used for the treatment of patients stricken by advanced heart failure. The HeartWare Ventricular Assist System uses the HVAD pump, a small-sized complete-output circulatory support device intended to be transplanted adjacent to the heart thereby obviating the abdominal surgery requisite for implanting certain devices produced by competing firms.

HeartWare has already obtained CE Mark for its new device in the European Union. Its device is currently facing clinical trials in the U.S. for two indications, namely, bridge to transplant under continuous access protocol as well as destination therapy. At this time, the HeartWare Ventricular Assist System is not available for commercial sale in the U.S.

HeartWare currently retains a Zacks #3 Rank, which translates into a short-term ‘Hold’ rating. The company competes in the heart device market with Thoratec Corporation (THOR) among others.

 
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