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News Breaks
November 20, 2012
14:45 EDTHTWRHeartWare confirms FDA approval for HeartWare Ventricular Assist System
HeartWare International confirmed that it has received approval from the United States Food and Drug Administration for the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. The HeartWare System is currently the leading ventricular assist device implanted in patients outside of the United States, having received CE Marking in the European Union in 2009, and Australian Therapeutic Goods Administration approval in 2011. In other clinical development for the HeartWare Ventricular Assist System, HeartWare has completed enrollment of a 450-patient destination therapy study at 50 U.S. sites. The final patients were implanted in May, with a two-year, primary endpoint follow-up period. HeartWare has requested a Continued Access Protocol allocation for destination therapy from the FDA. The company said, "Our team is positioned to commence the commercial rollout of the HeartWare System immediately, first facilitating broad use by the 50 U.S. hospitals that participated in our clinical studies, and then with training and expansion to additional U.S. hospitals."
News For HTWR From The Last 14 Days
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February 27, 2015
07:40 EDTHTWRHeartWare price target raised to $105 from $90 at Leerink
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February 26, 2015
07:03 EDTHTWRHeartWare reports 737 HeartWave Ventricular Assist Systems sold globally
U.S. revenue, generated through the sale of 382 units during the fourth quarter of 2014, was $41.5 million, a 60% increase from $25.9 million in the fourth quarter of 2013.
07:02 EDTHTWRHeartWare reports Q4 non-GAAP EPS (41c), consensus (59c)
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February 23, 2015
07:28 EDTHTWRHeartWare recall should not have material impact long-term, says Canaccord
Canaccord does not believe the voluntary recall issued by HeartWare should not have any material impact on its business long-term, as the serious event rate is relatively low. The recall pertains to a previously known issue and is in effect a continuation of its 2013 corrective action, Canaccord said. The firm reiterated its Buy rating and $115 price target on HeartWare shares.
February 20, 2015
16:35 EDTHTWRHeartWare issues recall of older HeartWare clinical trial controllers
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