Medtronic Announces Medicare Coverage Decision for the First and Only Leadless Pacemaker Available for Use in the U.S.
27 January 2017 - 1:00AM
CMS Decision
Expands Patient Access to the Micra®
Transcatheter Pacing System (TPS), the World's
Smallest Pacemaker
DUBLIN - Jan. 26, 2017 -
Medtronic plc (NYSE: MDT) today announced that the U.S. Centers for
Medicare and Medicaid Services (CMS) will cover leadless cardiac
pacemakers, as outlined in the agency's final National Coverage
Determination (NCD). This decision will provide Medicare patient
access to leadless pacemakers, consistent with the FDA-approved
labeling for the devices, through Medicare's policy of Coverage
with Evidence Development (CED).
"Medtronic is pleased with the CMS decision to cover leadless
pacemakers, which will allow broad patient access to this novel,
minimally invasive pacemaker technology through an innovative
approach to evidence and data collection to address research
questions identified by CMS," said John Liddicoat, M.D., senior
vice president, Medtronic, and president of the Cardiac Rhythm and
Heart Failure division. "We are working closely with CMS to ensure
patient access to the Micra TPS as quickly as possible under this
decision."
CED is a Medicare policy through which additional
evidence must be collected as a condition of coverage. The
leadless pacemaker decision will provide coverage for leadless
pacemakers when procedures are performed in FDA-approved
studies of leadless pacemakers and prospective longitudinal studies
approved by CMS. Under the policy, Medtronic will seek coverage of
the existing FDA-approved Micra Post-Approval Study (PAS) as a well
as a new study being finalized to track longitudinal data on Micra
patients in the Medicare population. Coverage for Micra will
become effective upon approval of these studies by CMS.
Approved by the U.S. Food and Drug Administration
(FDA) in April 2016 for patients who need a single-chamber
pacemaker, the Micra TPS is the first and only leadless pacemaker
approved for use in the U.S. The miniaturized device was recently
named at the top of US News & World Report's list of "2016's
Biggest Achievements in Medicine."
Comparable in size to a large vitamin, the Micra
TPS is less than one-tenth the size of traditional pacemakers, yet
delivers the most advanced pacing technology to patients via a
minimally-invasive approach. During the implant procedure, it is
attached to the heart with small tines and delivers electrical
impulses that pace the heart through an electrode at the end of the
device.
Unlike traditional pacemakers, the Micra TPS does
not require leads or a surgical "pocket" under the skin, so
potential sources of complications related to such leads and pocket
are eliminated - as are any visible signs of the device.
The Micra design incorporates a retrieval feature
which can be enabled, if necessary; however, the device is designed
to be left in the body. For patients who need more than one device,
the miniaturized Micra TPS can be permanently turned off, allowing
it to remain in the body so a new device can be implanted without
risk of electrical interaction.
The Micra TPS is the first and only leadless
pacing system to be approved for both 1.5 and 3 Tesla full-body
magnetic resonance imaging (MRI) scans. It is designed to allow
patients to be followed by their physicians and send data remotely
via the Medtronic CareLink® Network.
Remote monitoring of Micra devices is expected to be available
later this year.
In November 2015, preliminary results from the
Medtronic Micra TPS Global Clinical Trial, published in the
New England Journal of Medicine, showed the
Micra TPS was successfully implanted in 99.2 percent of patients
and that the system met its safety and effectiveness endpoints with
wide margins. In August 2016, new long-term data presented in a
late-breaking clinical trial at the European Society of Cardiology
congress continued to reinforce these results, demonstrating
consistent and sustained outcomes from early performance through
12-month follow-up.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services of
the highest quality that deliver clinical and economic value to
healthcare consumers and providers around the world.
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 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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.
-end-
Contacts:
Ryan Mathre
Public Relations
+1-763-514-9625
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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