Leading heart pump maker HeartWare International (HTWR) recently presented encouraging additional clinical data for the next-generation HeartWare Ventricular Assist System at the European Association for Cardio-Thoracic Surgery (“EACTS”) annual meet in Lisbon, Portugal.
The Massachusetts-based company reported updated results from the pivotal ADVANCE bridge to transplant (“BTT”) trial at the EACTS meet. ADVANCE is an Investigational Device Exemption (“IDE”) study intended to measure the effectiveness of the HeartWare Ventricular Assist System.
The results presented at the EACTS meeting combined data from 241 enrolled patients from two separate trials (ADVANCE and Continued Access Protocol/CAP). The updated clinical data revealed a high survival rate with 93% of the patients having survived for 180 days (or six months). Moreover, the data showed reduced thrombus (blood clot) events.
The HeartWare Ventricular Assist System is essentially a bridge to heart transplantation for patients suffering from end-stage heart failure (inability of the heart to pump enough blood). The device was cleared in the European Union in 2009 and in Australia in March 2011.
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 required for implanting certain devices offered by competing firms. The HVAD pump, which is at the core of the system, is a device capable of pumping up to 10 liters of blood per minute.
Currently, the HeartWare Ventricular Assist System is not available commercially in the U.S. The device is the subject of clinical trials in the U.S. for two indications, namely, BTT under continuous access protocol and destination therapy (“DT”). HeartWare submitted a Pre-Market Approval (“PMA”) application with the U.S. Food and Drug Administration (“FDA”) for the device for BTT indication in December 2010. The PMA includes data from the ADVANCE trial.
HeartWare makes miniaturized implantable heart pumps, also known as ventricular assist devices, which are used for the treatment of patients stricken by advanced heart failure. The company competes in the heart devices market with Thoratec Corporation (THOR) among others.
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