DOW JONES NEWSWIRES
HeartWare International Inc. (HTWR) filed a premarket approval application with the U.S. Food and Drug Administration for its heart-pump device for use in patients awaiting heart transplant.
The medical-device company's stock has more than doubled this year, with the most recent rally due to last month's announcement that the heart pump was able to keep more than 90% of patients alive six months after having received it. The study met a goal showing the device worked as well as other heart-pumping devices.
HeartWare's Ventricular Assist System poses a big threat to the current dominant position of Thoratec Corp's (THOR) HeartMate II mainly because of its smaller size, which means it requires less invasive surgery. The products, known as ventricular assist devices, help a damaged heart pump blood.
Shares were inactive premarket.
-By Lauren Pollock, Dow Jones Newswires; 212-416-2356; email@example.com