By Chris Wack

 

Medtronic PLC said it is stopping the distribution and sale of the Medtronic HVAD System.

The company said it has begun to notify physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support.

Medtronic said it is developing a support program for patients who have had an HVAD implanted and for caregivers and healthcare professionals who participate in their care. This program is being developed with an independent panel of clinician advisors to ensure the ongoing care and safety of patients who are currently supported by the HVAD system. The company said about 4,000 HVAD patients currently have the device implanted.

Medtronic said it saw 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.

Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient's heart condition, lead to a heart attack, require hospitalization, and result in death.

Medtronic has been working closely with the U.S. Food and Drug Administration, along with other regulatory bodies around the world, to share information related to this decision and its commitment to ongoing support for patients implanted with the HVAD device.

The company said its actions are expected to be neutral to slightly accretive to fiscal year 2022 adjusted earnings per share. The HVAD System and associated accessory revenue was $141 million in fiscal year 2021. The company is still expecting 2022 adjusted EPS of $5.60 to $5.75, and $1.31 to $1.34 in the first quarter.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

June 03, 2021 07:34 ET (11:34 GMT)

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