Leading heart pump maker HeartWare International will present clinical data for the next-generation HeartWare Ventricular Assist System at the European Association for Cardio-Thoracic Surgery (“EACTS”) annual meet on October 2.
The Massachusetts-based company will present results from the critical ADVANCE bridge to transplant (“BTT”) trial at the EACTS meet which will be held in Lisbon, Portugal. ADVANCE is an Investigational Device Exemption (“IDE”) study intended to measure the effectiveness of the HeartWare Ventricular Assist System.
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.
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.
Heart failure is a leading cause of deaths globally. The HeartWare Ventricular Assist System has been designed to specifically target the Class III and IV categories of advanced heart failure patients, an estimated 7 million patients globally. Roughly 20% of these patients are expected to benefit from the device, indicating a significant market opportunity.
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.
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 among others.
HeartWare’s sales more than doubled year over year in second-quarter 2011 to $20.4 million. The company sold 226 units of the HeartWare Ventricular Assist System globally in the quarter, up 95% year over year. Successful approval and commercialization of the device in the U.S. should further boost sales.