HeartWare (NASDAQ: HTWR) has received approval from the Food and Drug Administration for its Ventricular Assist System, the company and the FDA announced Tuesday.
The product is a mechanical heart pump that attaches directly to the organ in order to stimulate blood flow in end-stage heart failure patients. Unlike rival products, HeartWare's pump does not require surgical breach of the abdomen in order to be implanted.
According to the Massachusetts-based company, its product is the leading ventricular assist pump implanted in patients in non-U.S. markets, having received EU approval in 2009 and Australian approval in 2011. More than 2,500 patients have received the system.
HeartWare shares jumped on the news, advancing nearly 10%, or $7.53, to close at $89.54 on the day the announcements were made.