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.
Eric Volkman has no positions in HeartWare. The Motley Fool has no positions in HeartWare. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.