Medtronic to Stop Selling, Distributing HVAD System
June 03 2021 - 07:45AM
Dow Jones News
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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