World's Smallest Pacemaker, Medtronic Micra TPS, Wins Top European Innovation Award for 2015
(Thomson Reuters ONE) -
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 -
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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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Source: Medtronic plc via GlobeNewswire
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Datum: 24.06.2015 - 14:00 Uhr
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