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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; lauren.pollock@dowjones.com

Stock News for Heartware International (HTWR)
DateTimeHeadline
04/22/201513:00:00HeartWare Schedules First Quarter 2015 Conference Call And Webcast
04/21/201517:30:51Statement of Changes in Beneficial Ownership (4)
04/20/201517:29:25Proxy Statement - Notice of Shareholders Meeting (preliminary...
04/20/201516:30:00Contemporary Results From Commercial HVAD® System Registries...
04/20/201513:32:05HeartWare International Given New $94.00 Price Target at Oppenheimer...
04/16/201509:02:31Current Report Filing (8-k)
04/16/201504:22:00HeartWare Achieves Primary Endpoint In The ENDURANCE Destination...
04/16/201504:20:00HeartWare Achieves Primary Endpoint In The ENDURANCE Destination...
04/10/201519:00:00HeartWare Announces Webcasts At The 35th International Society...
04/10/201506:27:00HeartWare international est autorisée par Santé Canada à commercialiser le...
04/09/201507:30:00HeartWare International Receives Health Canada Approval For Commercialization...
04/09/201507:30:00HeartWare International Receives Health Canada Approval For Commercialization...
04/02/201517:09:18Statement of Changes in Beneficial Ownership (4)
03/30/201517:16:10Statement of Changes in Beneficial Ownership (4)
03/04/201509:00:00HeartWare Presentation At The 2015 Barclays Global Healthcare...
03/04/201507:00:00Sunshine Heart: There Is A Silver Lining To Those Clouds
02/26/201507:18:03Current Report Filing (8-k)
02/26/201507:07:42Heartware beats by $0.18, beats on revenue
02/26/201507:00:00HeartWare International Reports $73.2 Million In Fourth Quarter...
02/25/201517:37:00HeartWare Presentation At The Raymond James 36th Annual Institutional...

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