Medtronic to Stop Selling HVAD Implantable Heart Pump Over Safety Concerns
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
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
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 firstname.lastname@example.org
(END) Dow Jones Newswires
June 03, 2021 11:57 ET (15:57 GMT)
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