Medtronic Halts Sales of Heart Device Due to Risks of Strokes, Death

Medtronic Halts Sales of Heart Device Due to Risks of Strokes, Death

The company’s heart failure device, known as HVAD, was associated with a higher frequency of “neurological adverse events” compared to other products on the market.

Medtronic plc on Thursday announced that it has stopped selling a heart failure device due to greater risks of strokes and deaths in comparison to other products on the market.

Known as the Heartware Ventricular Assist Device, or HVAD, Medtronic’s product is a mechanical pump that moves blood for patients with advanced heart failure. The device is often implanted in patients who will eventually get a heart transplant. But some patients who aren’t eligible for a transplant may use the device indefinitely.

In a news release on Thursday, Medtronic pointed to a “growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.”

In a separate release, the U.S. Food and Drug Administration advised health care providers to stop implanting Medtronic’s HVAD system. The agency said it will work with Medtronic to monitor patients who already have had the device implanted. Both Medtronic and FDA stopped short of asking patients to get the device removed. The risks associated with removing the device, Medtronic said, outweigh any potential benefits.

For other patients, the FDA told physicians to use a different heart failure device manufactured by competitor Abbott Laboratories, which is based in Chicago but has a cardiovascular unit in Plymouth.

The agency noted that Medtronic’s HVAD system has been implanted in about 2,000 patients in the United States.

Medtronic has received over 100 complaints about the device delaying or failing to restart, according to the FDA. That led to 14 patient deaths, the agency said.

Abott, meanwhile, said it’s ready for an uptick in demand. In a statement on Thursday, the company said it has the “capacity and supply to effectively support the growing demand” for its own heart failure devices.

In 2016, Medtronic paid $1.1 billion to acquire Heartware International Inc., the maker of the HVAD system. At the time, Medtronic execs said the acquisition marked an important step toward “offering a complete suite of solutions to address patient needs across the heart failure care continuum.” Less than a year later, Abbott acquired Thoratec Corp., which makes a similar heart failure device.

The FDA first approved the HVAD system in November 2012.

In its 2021 fiscal year, the HVAD system pulled in $141 million in revenue for Medtronic. That same year, Medtronic had $30.1 billion in total revenue, and $3.6 billion in net income.

Medtronic has operational headquarters in Fridley, but is officially headquartered in Ireland for tax purposes.