New Data Further Support Medtronic Leadership in Leadless Pacing at Heart Rhythm 2016
May 05 2016 - 12:00PM
Data
Add to Body of Evidence Supporting World's Smallest
Pacemaker
Micra TPS is First Leadless Pacemaker to Receive FDA
Approval
DUBLIN and SAN FRANCISCO - May 5,
2016 - Medtronic plc (NYSE:MDT) today announced clinical
results highlighting the strong safety and performance profile of
the miniaturized Micra® Transcatheter Pacing System (TPS) at Heart
Rhythm 2016, the Heart Rhythm Society's 37th Annual Scientific
Sessions in San Francisco.
The Micra TPS is less than one-tenth the size of
traditional pacemakers and the only leadless pacemaker approved for
use in both the U.S. and Europe. Data presented today at HRS
further underscored the technology's safety and performance
profile. The data also confirmed Micra's ability to accurately
respond to patients' activity levels by adjusting therapy using for
the first time an accelerometer sensor positioned within the
heart.
"Many patients with bradycardia require
rate-responsive pacing so that their heart rates increase during
exercise," said Razali Omar, M.D., senior consultant cardiologist
at the National Heart Institute in Kuala Lumpur, Malaysia.
"Conventional pacemakers use various sensors outside the heart to
detect patient activity, but even these sensors can have difficulty
detecting moderate physical activity. As data presented today show,
the Micra accurately responds to patients' activity levels by
adjusting therapy when needed using a sensor within the heart."
Using a miniaturized sensor to measure a patient's
movement (also known as an accelerometer), the Micra TPS determines
which pacing rates are appropriate based on patient activity
levels. The technology is the first FDA-approved cardiac device to
position the sensor inside the heart and the only leadless
pacemaker to offer the benefits of accelerometer-based sensing
technology, the industry standard for traditional pacemaker
systems.
Data presented today at HRS assessed the rate
response performance for approximately 20 patients with Micra TPS
at three- and six-months post-implant procedure. In the study,
patients underwent treadmill tests exercising to maximal exertion.
The study found that appropriate rate-responsive pacing is
achievable with an entirely intracardiac accelerometer-based pacing
system.
Comparable in size to a large vitamin, the Micra
TPS 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
to enable retrieval 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 was designed with a unique feature that
enables it to be permanently turned off so it can remain in the
body and a new device can be implanted without risk of electrical
interaction.
Micra TPS is the first and only leadless pacing
system to be approved for both 1.5 and 3 Tesla (T) full-body
magnetic resonance imaging (MRI) scans, providing patients with
access to the most advanced imaging diagnostic procedures
available.
In November 2015, data from the Medtronic Micra
TPS Global Clinical Trial were published in the New England Journal
of Medicine and presented during a late-breaking Special Report at
the American Heart Association Scientific Sessions. Data showed the
Micra TPS was successfully implanted in 99.2 percent of patients,
there were no (0) dislodgements, and the system met its safety and
effectiveness endpoints with wide margins.
The Micra TPS was awarded CE Mark in April 2015
and U.S. Food and Drug Administration (FDA) approval in April 2016.
It is intended for use in patients who need a single-chamber
pacemaker. The device was 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 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
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 85,000 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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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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