HeartWare International Inc. is a global medical device company dedicated to delivering safe, high-performing and transformative therapies that enable patients with heart failure to get back to life. The company’s innovative technologies are creating advances in the miniaturization of Ventricular Assist Devices (VADs) leading to less invasive surgical procedures and increasing the patient population who may be suitable for VAD therapy.
Heart failure is a degenerative, terminal disease affecting more than 20 million patients worldwide and causing more than 7.25 million deaths each year. Approximately 1 million patients suffer from Class IV heart failure, the most severe stage of the disease. Heart transplantation is a proven treatment option for Class IV heart failure patients, but a limited number of donor hearts become available each year. Ventricular assist devices can provide circulatory support until a donor heart becomes available (called bridge-to-transplant therapy), or, provide long- term support as an alternative to transplantation (called destination therapy in many countries).
HeartWare’s breakthrough innovations begin with the company’s miniaturized ventricular assist device, called the HVAD® Pump, designed to be implanted next to the heart in the pericardial space avoiding the more invasive surgical procedures required with older LVAD technologies.
The HeartWare Ventricular Assist System obtained U.S. market approval in 2012 from the U.S. Food and Drug Administration (FDA) as a bridge-to-transplant therapy for patients with advanced stage heart failure. The HeartWare® System has been commercially available in other global markets including Europe and Australia, since 2009. To date, more than 9,000 patients worldwide have been treated with the HeartWare Ventricular Assist System.
HeartWare’s corporate headquarters are in Framingham, Massachusetts. The company’s operating and manufacturing activities are based in Miami Lakes, Florida, and Sydney, NSW, Australia.