The Food and Drug Administration announced Tuesday that it has approved Framingham, Massachussetts-based HeartWare’s left ventricle assist device for heart failure patients awaiting a heart transplant.
The HeartWare Ventricular Assist System is a mechanical, implantable pump that helps the heart’s left ventricle pump blood that is rich in oxygen to the body in patients whose hearts are too weak to function on their own.
In its news release, the agency explained that the miniature assist device is so small, that it can be implanted in the chest near the heart while other LVAD devices and components are implanted in the stomach.
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On its website, HeartWare indicates that 1 million patients are in the very late stages of heart failure but have to wait to get a donor heart for a transplantation. The company’s HVAD pump can keep the heart functioning and providing circulatory support until a donor heart becomes available.
The company, which trades on the Australian Stock Exchange, recently reported revenue of $22.8 million in the quarter ended Sept. 30, up from $21.3 million in the same period a year ago. Loss widened to nearly $25 million, or $1.75 per share, from nearly $14 million, or $1 per share in the same year-before period.
