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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)
11/25/201508:14:34Amended Annual Report (10-k/a)
11/24/201512:30:00HeartWare Presentation At The Piper Jaffray 27Th Annual Healthcare...
11/19/201516:34:25Current Report Filing (8-k)
11/19/201516:32:15Filing of Certain Prospectuses and Communications in Connection...
11/13/201507:33:53Current Report Filing (8-k)
11/13/201507:32:08Filing of Certain Prospectuses and Communications in Connection...
11/12/201518:56:00Lifshitz & Miller Law Firm Announces Investigation of C1 Financial...
11/12/201508:55:00HeartWare Presentation At The Canaccord Genuity 2015 Medical...
11/12/201507:34:13Current Report Filing (8-k)
11/12/201507:32:23Filing of Certain Prospectuses and Communications in Connection...
11/11/201515:02:00SHAREHOLDER ALERT: Levi & Korsinsky, LLP Announces the Commencement...
11/10/201517:30:00Bragar Eagel & Squire, P.C. Is Investigating the Officers & Directors...
11/06/201508:55:00HeartWare Presentation At The Credit Suisse 24th Annual Healthcare...
11/03/201517:04:22Current Report Filing (8-k)
11/03/201517:02:39Filing of Certain Prospectuses and Communications in Connection...
11/03/201508:00:00HeartWare International Announces Expiration Of Hart-Scott-Rodino...
11/02/201517:04:42Quarterly Report (10-q)
10/30/201502:41:42Heartware Hopes For Heart Pump Treat, Not Trick
10/29/201520:58:00ALERT: Khang & Khang LLP Announces an Investigation of Claims...
10/29/201507:19:01Current Report Filing (8-k)

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