Heartware International, a cardiac device manufacturer based in Framingham, Massachusetts, recently received premarket approval (PMA) from the United States Food and Drug Administration for its ventricular assist system. The ventricular assist system will be used as a bridge to heart transplant.
The new device by Heartware comprises an external driver, a power source, and an implantable pump. According to information from the FDA, the power source that the device uses can be used in both residential settings and hospitals.
Christy Foreman is the director at the FDA’s Center for Devices & Regulatory Health. In the notice, she remarked that the new Heartware system is a great choice for patients who are waiting for a donor heart. Since the demand for donor hearts always exceeds the supply, the Heartware system can provide a valuable lifeline for patients in need of a transplant. Most other heart pumps on the market require the installation of components in the abdomen. With the HeartWare system, a small implant only needs to be placed near the heart. This makes the HeartWare system a great choice for patients who can’t have an implant inside their abdomens.
According to a notice by the U.S. regulatory agency, "The FDA approved the HeartWare LVAD based on data from a clinical trial known as the ADVANCE trial.” The notice continued, "The trial compared outcomes from 137 advanced heart failure participants using the HeartWare System with outcomes from similar patients followed by the Interagency Registry for Mechanically Assisted Circulatory Support."