World's Smallest Pacemaker, Medtronic Micra TPS, Featured in Late-Breaking Trial Session at EUROPACE 2015
(Thomson Reuters ONE) -
Global clinical trial finds Medtronic Micra Transcatheter Pacemaker Meets
Initial Safety and Performance Measures
DUBLIN and MILAN - June 22, 2015 - Medtronic plc (NYSE: MDT) today reported
study results of its Micra(®) Transcatheter Pacing System (TPS) at a late-
breaking clinical trials session at EHRA EUROPACE-CARDIOSTIM 2015 in Milan. The
study results demonstrated that the miniaturized pacemaker met initial safety
and performance measures in its global clinical trial.
Of the first 140 patients who received the Micra TPS, 100 percent were
successfully implanted. At one- and three-month follow ups, all patients had
mean electrical pacing measurements within expected ranges.
"The initial results for this novel device are quite promising, and similar to
results seen with conventional pacemakers," said Philippe Ritter, M.D.,
principal investigator of the Micra TPS Global Clinical Trial and cardiologist
at University Hospital of Bordeaux. "Patients in this study have fared very
well, and if the strong safety and performance profile of the Micra TPS
continues with more patients and over the long-term, this transcatheter pacing
therapy will prove to be a simpler, less-invasive pacemaker option while
maintaining therapy effectiveness."
The first 140 patients in the Medtronic Micra TPS Global Clinical Trial were
implanted by 37 physicians at 23 sites across Asia-Pacific, Europe and the
United States. 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) Importantly, there were no infections or
dislodgments, and no events required surgical re-operation or resulted in death.
Further, there were no (0) unanticipated serious adverse device events (assumed
<5 percent).
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 initial results from the clinical trial also were published in the
European Heart Journal, Early performance of a miniaturized leadless cardiac
pacemaker: the Micra Transcatheter Pacing Study.(2)
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. The small size and
short length of the Micra device allows physicians to implant more than one
device within the heart, if needed.
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. 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.
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. The trial is ongoing and will continue to evaluate
the safety and efficacy of the device through a single-arm, multi-center study
that has enrolled more than 700 patients at 56 centers in 19 countries.
In the United States, the Micra TPS is an investigational device and not yet
approved for commercial use.
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: 22.06.2015 - 15:12 Uhr
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