Medtronic Announces Japanese Regulatory Approval for Micra(TM) Transcatheter Pacing System (TPS)
February 17 2017 - 8:00AM
DUBLIN - Feb. 17, 2017 -
Medtronic plc (NYSE: MDT) today announced Japan regulatory approval
for the world's smallest pacemaker, the Micra(TM) Transcatheter
Pacing System (TPS). Japan's Pharmaceuticals and Medical Device
Agency (PMDA) granted approval for Micra based on positive data
from the Medtronic Micra TPS Global Clinical Trial, which enrolled
744 patients and evaluated the safety and efficacy of the device
through a single-arm, multi-center study at 56 centers in 19
countries, including Japan.
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 United States. Micra was recently named at the top of US News
& World Report's list of "2016's Biggest Achievements in
Medicine." It is approved for both 1.5 and 3 Tesla full-body
magnetic resonance imaging (MRI) scans.
"The development of a leadless pacemaker which can
be implanted with a less invasive procedure has been eagerly
awaited by physicians and patients in Japan," said Kyoko Soejima,
M.D., professor of cardiovascular internal medicine at Kyorin
University. "The safety and efficacy of the Micra TPS has been
confirmed in my hospital as well as in other hospitals across the
world that took part in the Micra TPS Global Clinical
Trial."
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.
"Medtronic is excited to be the first to offer a
miniaturized, leadless pacemaker to patients in Japan," said John
Liddicoat, M.D., senior vice president, Medtronic, and president of
the Cardiac Rhythm and Heart Failure division. "We look forward to
working with Japan's Ministry of Health, Labor and Welfare to gain
reimbursement for Micra so patients can gain access to this
innovative technology as quickly as possible."
The Micra design incorporates a retrieval feature
which can be enabled when possible; 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.
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
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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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