World's Smallest Pacemaker, Medtronic Micra TPS, Wins Top European Innovation Award for 2015
June 24 2015 - 8:00AM
Award Follows
Late-breaking Presentation Showing Medtronic Micra
Transcatheter Pacemaker
Meets Initial Safety and Performance
Measures
DUBLIN and MILAN - June 24,
2015 - Medtronic plc (NYSE: MDT) today announced that its
Micra® Transcatheter
Pacing System (TPS) has won the top innovation award for practice
improvement at EHRA EUROPACE-CARDIOSTIM 2015 in Milan. The award is
selected by an international panel of experts, scientists and
physicians who review the competing products and choose the
"ultimate innovation."
Today's award follows a late-breaking presentation
of study results from the Micra TPS global clinical trial, which
demonstrated that the miniaturized pacemaker met its initial safety
and performance measures.
At less than one-tenth the size of traditional
pacemakers, the Micra TPS 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. Once positioned, the Micra TPS
can be repositioned or retrieved, if needed. The device responds to
patients' activity levels by automatically adjusting therapy.
Unlike traditional pacemakers, the Micra TPS does not require a
surgical "pocket" under the skin, so potential sources of
complications from this type of implantation are eliminated-as are
any visible signs of the device.
The Micra TPS was commercially launched in Europe
earlier this month after being awarded CE (Conformité Européenne)
Mark based on data from the Medtronic Micra TPS Global Clinical
Trial. Micra TPS also is the first transcatheter pacing system to
be awarded CE (Conformité Européenne) Mark for 1.5T and 3T full
body MRI scanning, providing patients with access to the most
advanced imaging diagnostic procedures.
In the United States, the Micra TPS is an
investigational device and not yet approved for commercial
use.
"We are honored to accept this award on behalf of:
the scientists who, through their dedication to innovation and
advancing patient care, found a way to miniaturize the size of the
pacemaker while maintaining the most advanced pacing technology
available; the investigators who rigorously evaluated the system;
and the patients who ultimately will benefit from this innovation,"
said John Liddicoat, M.D., senior vice president, Medtronic,
and president of the Cardiac Rhythm and Heart Failure Business.
"The award is especially meaningful from EUROPACE-CARDIOSTIM, the
preeminent scientific congress for electrophysiology in
Europe."
Of the first 140 patients in the Micra TPS global
clinical trial, 100 percent were successfully implanted. At one-
and three-month follow ups, all patients had mean electrical pacing
measurements within expected ranges. The patients were implanted by
37 physicians at 23 sites, and they spanned a wide variety of
patient profiles such as age (from 21 to 94 years), weight (ranging
from 41 to 148 kilograms), and residence (including Asia-Pacific,
Europe and the U.S.). Patients considered to be at high risk also
participated in the study, including patients with lung disease
such as COPD (chronic obstructive pulmonary disease) and pulmonary
hypertension.
Of the 140 patients followed for an average of 1.9
months, eight patients experienced a serious adverse event and most
of these were easily managed; only two patients (1.4 percent)
experienced events which resulted in prolonged hospitalization.
This rate is in line with rates observed in studies of traditional
pacemakers.1 Testing of
electrical performance at three months showed the pacing threshold
was lower (0.51V at 0.24ms) than the pre-specified performance
objective (<2.0V at 0.24ms), resulting in an expected average
longevity of at least 10 years.
These clinical trial results also were published
in the European Heart Journal, Early performance of a miniaturized leadless cardiac
pacemaker: the Micra Transcatheter Pacing Study.2
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 Udo et al. FOLLOWPACE.
Heart Rhythm
2012;9:729
2 European Heart Journal,
doi:10.1093/eurheartj/ehv214
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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