Hedquartered in Framingham, MA, with Operations, Manufacturing and Distribution in FL, MN, Germany and Australia, HeartWare International, Inc. develops and manufactures small implantable heart pumps or ventricular assist devices for the treatment of advanced heart failure. Having recently outgrown SBIR size limitations through an active program of acquisitions, the company offers HeartWare Ventricular Assist System, which includes a left ventricular assist device, or blood pump, patient accessories, and surgical tools designed to provide circulatory support for patients in the advanced stage of heart failure. HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 37 countries. The device is also currently the subject of a U.S. clinical trial for destination therapy.
