BOSTON/CHICAGO, Feb 23 (Reuters) - A leading hospital for implanting mechanical heart devices has suspended use of an experimental heart pump made by HeartWare International Inc after a patient ...
Five years after Medtronic's billion-dollar purchase of HeartWare International, the company discontinued the device at the center of acquisition — a miniaturized, implantable heart pump — with no ...
BOSTON/CHICAGO, April 16 (Reuters) - Patients implanted with a mechanical heart-assistance device made by HeartWare International Inc <HTWR.O> have an unexpectedly high 9.2 percent chance of ...
A year after pulling its HeartWare Ventricular Assist Device (HVAD) System from the market, Medtronic is still dealing with regulatory issues associated with the device. In a recent update, FDA called ...
Medtronic's HeartWare HVAD pump system has been hit with a slew of recalls in recent months and the rate of device malfunction reports documented since it's been on the market in an FDA database ...
HeartWare International (HTWR), a leading manufacturer of heart devices, recently submitted a Pre-Market Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”), for its ...
FRAMINGHAM, Mass., HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, ...
The US Food and Drug Administration is alerting physicians about a heart pump recall initiated late last year: Medtronic issued a recall for its HeartWare ventricular assist device (VAD) pump implant ...
On 22 March 2006, a 48 year old male patient suffering NYHA Class IV Heart Failure became the first recipient of HeartWare's HVAD mechanical circulatory assist device. The implant was conducted at the ...
Thousands of HVADs could have faulty battery cells. Nancy Crotti HeartWare International is recalling more than 18,000 batteries for ventricular assist devices it sold between 2013 and 2015, the ...
Medtronic, Inc. is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to ...
CHICAGO, Nov 18 (Reuters) - A rivalry between HeartWare Inc and Thoratec Corp erupted into a high-stakes battle this week at the world's biggest annual cardiology meeting, where the medical device ...
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