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May 1, 2014
06:58 EDTHTWRHeartWare issues voluntary device correction for HeartWare batteries
HeartWare issued a voluntary Urgent Medical Device Correction related to all HeartWare Ventricular Assist System batteries, product codes 1650 and 1650-DE. In letters to clinicians and patients, the company reports an observed increase in complaints related to earlier-than-expected battery depletion and routine battery handling. HeartWare is providing information to assist patients and clinicians in monitoring battery performance, recognizing abnormal behaviors and reinforcing proper power management. Premature or unrecognized deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. If a battery shows abnormal behavior, patients are instructed to stop using that battery and contact their VAD Coordinator for a replacement. No deaths have been reported to HeartWare that were directly related to a faulty battery. However, between January 1, 2011 and March 31, three deaths were reported that were potentially related to power source management. Of those, two patient deaths occurred after both sources of power were simultaneously disconnected; the third patient had batteries that far exceeded their expected useful life. A fourth death was originally reported as possibly related to power management, but was later determined to be more likely related to an accidental disconnection of the driveline. Clinicians and patients are encouraged to review the correction letters and the Patient Manual to ensure proper power management.
News For HTWR From The Last 14 Days
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April 16, 2015
09:52 EDTHTWRThoratec comments on HeartMate II data in ENDURANCE therapy trial
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08:53 EDTHTWRBofA/Merrill medical technology analysts hold analyst/industry conference call
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05:32 EDTHTWRHeartWare achieves primary endpoint in ENDURANCE clinical trial
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April 11, 2015
14:10 EDTHTWRLeerink medical devices analyst holds an analyst/industry conference call
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April 10, 2015
08:37 EDTHTWRThoratec price target raised to $50 from $45 at Leerink
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April 9, 2015
07:32 EDTHTWRHeartWare receives Health Canada approval for commercialization of assist system
HeartWare announced that it has received approval from Health Canada, the country's federal department responsible for helping Canadians maintain their health, to market the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.
April 7, 2015
10:48 EDTHTWRLeerink medical supplies & devices analyst has analyst/industry conference call
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April 6, 2015
08:58 EDTHTWRCredit Suisse more optimistic on HeartWare
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