Medtronic ends sales of heart-failure device after adverse events

 

Glen Stubbe, Star Tribune file

Fridley-based Medtronic is discontinuing all implants of one of its most complex and costly heart-failure devices, the HeartWare Ventricular Assist Device.

Medtronic PLC is discontinuing all implants of one of its most complex and costly heart-failure devices, the HeartWare Ventricular Assist Device, five years after the Minnesota device maker acquired the HVAD's maker in a $1.1 billion deal.

Medtronic and the U.S. Food and Drug Administration announced Thursday that the device should no longer be implanted following reports that the system - which circulates oxygenated blood when the patient's heart is failing - is associated with more deaths, strokes and device problems than a competing system made by Abbott Laboratories.

Medtronic has reported more than 100 patient complaints involving a delay or failure in restarting the devices' implantable blood pump, "which led to a total of 14 deaths and 13 pump removals," the FDA says. About 2,000 HVADs are currently implanted in the U.S., out of 4,000 implants worldwide.


https://www.startribune.com/medtronic-ends-sales-of-heart-failure-device/600064270/

 

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