Abbott (NYSE: ABT) today announced the company has capacity and supply to effectively support the growing demand for mechanical circulatory support (MCS) devices for the effective treatment of advanced heart failure following Medtronic's decision to stop the global distribution and sale of the Medtronic HeartWare™ .
/PRNewswire/ Abbott (NYSE: ABT) today announced the company has capacity and supply to effectively support the growing demand for mechanical circulatory.
Abbott today announced the company has capacity and supply to effectively support the growing demand for mechanical circulatory support devices for the effective treatment of advanced heart failure following Medtronic's decision to stop the global distribution and sale of the Medtronic HeartWare™ ventricular assist device . Abbott is also supporting training and education programs for additional physicians who .
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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 outpaces competing products.
So far this year, the FDA issued three Class I recalls for the system, including issues with delayed or stalled restarts and updates to instructions for use. However, issues with the system go back to nearly as early as the product received its premarket approval from the FDA in 2012, about four years before Medtronic acquired the product through its $1.1 billion buy up of HeartWare International.