By Dave Sebastian 

Medtronic PLC said it is stopping the distribution and sale of its implantable heart pump in light of clinical data suggesting more frequent deaths and neurological events such as stroke compared with other circulatory-support devices.

The medical-device company on Thursday said it notified physicians to stop new implants with the HVAD System device and transition to other means of mechanical circulatory support. The company said it is developing recommendations to reduce stroke and other risks associated with the device with an independent panel of clinician advisers.

Medtronic said it is starting a support program for patients who have had the device implanted and for caregivers and healthcare professionals. The support will include financial assistance for eligible patients, Medtronic said. The company added that it plans to put out more details about the program in the future.

Medtronic previously told physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. It said the failure in pump restart could lead to heart attack and death after worsening a patient's heart condition.

"We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians," said Nnamdi Njoku, president of Medtronic's mechanical circulatory support business.

The company said it doesn't recommend patients who are already implanted with HVAD System to take the device out, as the risks could outweigh potential benefits. Medtronic said there are about 4,000 HVAD patients currently implanted with the device.

Medtronic said it is working with competitor Abbott Laboratories, which makes the HeartMate 3 heart pump, and regulatory bodies to help ensure patients have access to left ventricular assist devices, or LVAD. Abbott said it has the capacity to support the growing demand for its mechanical circulatory support devices. It is supporting training and education programs for physicians who will now be offering the heart pump to patients, Abbott said.

Medtronic said the halting of the HVAD System distribution could be neutral to its fiscal 2022 adjusted per-share earnings or give them a slight boost. Revenue from the HVAD System and associated accessories was $141 million for fiscal 2021, Medtronic said, and the company included the potential loss of revenue in its May 27 guidance. The company said it continues to expect adjusted earnings of $5.60 a share to $5.75 a share on a 9% organic revenue growth for fiscal 2022.

"We see this as a neutral event for Medtronic and a minor positive to Abbott, which we expect should capture almost all of the lost HVAD sales as the only competitor on the market," JPMorgan Chase & Co. analysts said in a note to clients.

Write to Dave Sebastian at dave.sebastian@wsj.com

 

(END) Dow Jones Newswires

June 03, 2021 11:57 ET (15:57 GMT)

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