Leading heart pump maker HeartWare International (HTWR) has received approval of the Australian Therapeutic Goods Administration (“TGA”) for its next-generation HeartWare Ventricular Assist System. The device is essentially a bridge to heart transplantation for patients suffering from end-stage heart failure.
The TGA approval represents a major milestone for the Massachusetts-based company, helping it expand the addressable market for the device.
Heart failure is a leading cause of death 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 requisite 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. More than 900 people with advanced heart failure have already received the pump globally.
HeartWare has obtained CE Mark for the HeartWare Ventricular Assist System in the European Union in 2009. The device is the subject of clinical trials in the U.S. for two indications, namely, bridge to transplant (“BTT”) under continuous access protocol and destination therapy (“DT”). Besides Europe, it is currently available in other countries on a limited basis and under special access programs.
Currently, the HeartWare Ventricular Assist System is not available commercially in the U.S. 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 company’s critical ADVANCE clinical trial, an Investigational Device Exemption (“IDE”) study intended to measure the effectiveness of the device.
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.
HeartWare’s sales more than doubled year over year in 2010 to $55.2 million, roughly two-thirds of which came from the international markets driven by increased penetration of the HeartWare Ventricular Assist System. Successful approval and commercialization of the device in the U.S. should further boost the company’s future revenues.
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