HeartWare Files FDA Application For Heart-Pump Device
December 28 2010 - 8:48AM
Dow Jones News
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;
lauren.pollock@dowjones.com
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