- Company Developing Support Program for Current HVAD
Patients
- Medtronic Coordinating with Global Regulators to Assure
Patient Access to Left Ventricular Assist Devices
DUBLIN, June 3, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, is stopping
the distribution and sale of the Medtronic HVAD™ System. This
morning, the company notified physicians to cease new implants of
the HVAD System and transition to an alternative means of durable
mechanical circulatory support.
Medtronic also announced that it is developing a support program
for patients who have had an HVAD implanted and for caregivers and
health care 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. Though the company will
stop distribution and sale of the HVAD System, Medtronic is
committed to serving the needs of the approximately 4,000 HVAD
patients currently implanted with the device.
Medtronic initiated this action in light of 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 addition, 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.
Considering these findings and the availability of alternative
devices, Medtronic made the decision to stop the distribution and
sale of the HVAD System, consistent with its commitment to
prioritize patient safety.
"The Medtronic Mission guides us to always do what is in the
best interests of patients and that is exactly what we are doing
and will do for those impacted by this decision. There is nothing
more important than the safety and well-being of patients," said
Nnamdi Njoku, president of the
Mechanical Circulatory Support business, which is part of the
Cardiovascular Portfolio at Medtronic. "We recognize this
information may be concerning for patients and their caregivers,
and Medtronic is committed to supporting them in coordination with
their physicians."
Medtronic has been working closely with the U.S. Food
and Drug Administration (FDA), 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.
Patient Management Recommendations
Medtronic is
committed to patient safety and to serving the needs of the
approximately 4,000 HVAD patients currently implanted with the
device. Medtronic has consulted with an independent panel of
clinician advisors to develop patient management recommendations to
reduce stroke risk and mitigate against other potential risks
associated with the HVAD System. Elective explant of the HVAD
device is not recommended, as risks associated with explantation
may outweigh the potential benefits.
Medtronic is also developing an ongoing support program for
patients who have had an HVAD implanted, caregivers, and health
care professionals who participate in their care. The program will
include financial assistance for eligible patients and other
resources for physicians and their caregivers. Further details of
the program will be announced when they become available.
Medtronic is working closely with other stakeholders including
Abbott, which manufactures the HeartMate 3™ LVAD device, and with
regulatory bodies globally, to help ensure that alternative
treatment options are available for patients who may be candidates
for a LVAD device.
Patients with a HVAD implanted should contact their physician
with questions or concerns. For more information, please visit
www.Medtronic.com/HVADsafety.
Financial Information
In terms of financial impact,
the company estimates that on a non-GAAP basis, the actions
announced today are expected to be neutral to slightly accretive to
fiscal year 2022 non-GAAP diluted earnings per share (EPS). The
HVAD System and associated accessory revenue was $141 million in fiscal year 2021. In addition,
the potential loss of revenue was contemplated in the guidance
issued by the company on May 27,
2021. As such, there is no change to:
- the 9% organic revenue growth outlook for fiscal year
2022;
- the Cardiovascular organic revenue growth outlook of 10-11% for
fiscal year 2022, including 14-15% in the first quarter; and
- the diluted non-GAAP EPS guidance of $5.60 to $5.75 for
fiscal year 2022, including the first quarter outlook of
$1.31 to $1.34.
About the HVAD™ System
The Medtronic HVAD System is
indicated for hemodynamic support in patients with advanced,
refractory left ventricular heart failure; either as a Bridge to
Cardiac Transplantation (BTT), myocardial recovery, or as
Destination Therapy (DT) in patients for whom subsequent
transplantation is not planned.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
HeartMate 3 is a trademark of Abbott group of companies.
Contacts:
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Kathleen
Janasz
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Ryan
Weispfenning
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Public
Relations
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Investor
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+1-763-526-3676
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+1-763-505-4626
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SOURCE Medtronic plc