Medtronic Announces CE Mark of World's Smallest Pacemaker, Micra Transcatheter Pacing System
April 14 2015 - 9:00AM
Miniaturized
Device Less Than One-tenth the Size of a Conventional Pacemaker
and Placed Directly in the Heart
DUBLIN - April 14, 2015 -
Medtronic plc (NYSE: MDT)today announced it has received CE
(Conformité Européenne) Mark of the Micra® Transcatheter Pacing
System (TPS), the world's smallest pacemaker. At less than
one-tenth the size of traditional pacemakers, the Micra device
provides the most advanced pacing technology available while being
cosmetically invisible and small enough to be delivered with
minimally invasive techniques through a catheter, and implanted
directly into the heart.
Comparable in size to a large vitamin, the Micra
TPS does not require the use of wires, known as "leads," to deliver
pacing therapy; rather, it is attached to the heart via 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 are eliminated - as are any
visible signs of the device," said Philippe Ritter, M.D.,
cardiologist at Hôpital Cardiologique de Haut Lévêque and Centre
Hospitalier Universitaire (CHU) Bordeaux. "While the Micra TPS is
dramatically smaller, it is a fully self-contained pacemaker that
still delivers the most advanced pacing technology available to
patients."
Once positioned, the Micra TPS is attached to the
heart wall and can be repositioned or retrieved, if needed. The
device responds to patients' activity levels by automatically
adjusting therapy. Despite its miniaturized size, the Micra TPS has
an estimated 10-year battery life and is approved for full body MRI
scans, providing patients with access to the most advanced imaging
diagnostic procedures.
The device was awarded CE Mark based on results
from the first 60 patients (at three months) in the Medtronic Micra
TPS Global Clinical Trial. The trial is ongoing and will continue
to evaluate the safety and efficacy of the device through a
single-arm, multi-center study that will enroll up to 780 patients
at approximately 50 centers in 20 countries. Initial results from
the Micra TPS Global Clinical Trial will be revealed for the first
time at a late-breaking clinical trials session at the Heart Rhythm
Society's 2015 Annual Scientific Sessions in May.
In the U.S., the Micra TPS is an investigational
device and not yet approved for commercial use.
"Our cross-functional teams have been working for
years to redefine engineering limits and production capabilities by
radically reducing the size of medical devices by more than 90
percent while continuing to innovate upon the existing technology,"
said Brian Urke, vice president and general manager of the Cardiac
Rhythm and Heart Failure's Brady business, which is part of the
Cardiac and Vascular Group at Medtronic. "We believe our investment
in this research is transforming cardiac care and will provide more
and better therapy options to patients."
Pacemakers help restore the heart's rhythm by
sending electrical signals to the heart to increase the heart rate,
which can relieve the symptoms of bradycardia. Pacemaker therapy is
the most common way to treat bradycardia (a slow heartbeat), with
more than one million pacemakers implanted worldwide each
year.1 The Micra
device is available for patients who benefit from single-chamber
pacing as it paces one chamber of the heart, the right
ventricle.
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 the global leader in medical technology - alleviating
pain, restoring health and extending life for millions of people
around the world.
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 -
1 Mond HG,
Proclemer A. The 11th world survey of cardiac pacing and
implantable cardioverter-defibrillators: calendar year 2009 -- a
World Society of Arrhythmia's project. Pacing Clin
Electrophysiol. 2011 Aug;34(8):1013-27.
Contacts:
Kathleen Janasz
Public Relations
+1-763-526-3676
Jeff Warren
Investor Relations
+1-763-505-2696
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information contained therein.
Source: Medtronic plc via Globenewswire
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