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HeartWare Files FDA Application For Heart-Pump Device

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;

Stock News for Heartware International (HTWR)
10/09/201514:44:42Boston Arrives Late To The Mitral Valve Party
10/09/201511:11:00Valtech's CE Mark-Approved Cardioband® for Transcatheter Mitral...
10/05/201516:19:18Current Report Filing (8-k)
10/05/201516:17:35Filing of Certain Prospectuses and Communications in Connection...
10/05/201508:00:00Engaged Capital Urges HeartWare International to Terminate Proposed...
10/05/201507:30:00Heartware Issues Statement Regarding Engaged Capital Comments
10/02/201516:18:58Current Report Filing (8-k)
10/02/201516:17:16Filing of Certain Prospectuses and Communications in Connection...
09/29/201507:15:20Current Report Filing (8-k)
09/29/201507:02:08Filing of Certain Prospectuses and Communications in Connection...
09/19/201516:30:00Valtech Cardio to Host Cardioband® Symposium, Following Receipt...
09/14/201507:18:34Current Report Filing (8-k)
09/14/201507:16:24Filing of Certain Prospectuses and Communications in Connection...
09/09/201516:44:49Current Report Filing (8-k)
09/09/201516:42:38Filing of Certain Prospectuses and Communications in Connection...
09/09/201509:17:07Current Report Filing (8-k)
09/08/201507:43:41Current Report Filing (8-k)
09/08/201507:41:59Filing of Certain Prospectuses and Communications in Connection...
09/03/201510:00:00HeartWare Presentation At The 2015 Wells Fargo Healthcare Conference...

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