Global Clinical Trial Finds Medtronic Micra® Transcatheter Pacemaker Meets Initial Safety and Performance Measures
May 15 2015 - 8:00AM
Initial Safety and
Performance Data of World's Smallest Pacemaker Featured in
Late-Breaking Session at Heart Rhythm 2015
DUBLIN and BOSTON - May 15,
2015 - Medtronic plc (NYSE: MDT) today announced study results
of its Micra® Transcatheter
Pacing System (TPS), which demonstrated that the miniaturized
pacemaker has met its initial safety and performance measures. In
the largest report to date of a transcatheter pacing system, 100
percent of the first 140 patients who received the Micra TPS
experienced a successful implant procedure, and mean electrical
pacing measurements at all patient visits (one- and three--month
follow up) were within expected ranges. These data, from the
Medtronic Micra TPS Global Clinical Trial, were presented today
during a Late-Breaking Clinical Trials session at Heart Rhythm
2015, the Heart Rhythm Society's 36th Annual Scientific Sessions in
Boston.
"These initial data are quite promising, as
patients in this study have fared very well with this novel
device," said Philippe Ritter, M.D., principal investigator of the
Micra TPS Global Clinical Trial and cardiologist at University
Hospital of Bordeaux. "If the strong safety and performance profile
of the Micra TPS that we've seen so far persists over the long-term
and in more patients, this transcatheter pacing therapy will prove
to be an effective but simpler and less-invasive pacemaker option
for many patients."
The first 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.
The 140 patients spanned a wide variety of patient
profiles, including high-risk 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.
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 are eliminated-as are any visible signs of
the device.
The Micra TPS was awarded CE (Conformité
Européenne) Mark in April 2015 based on the 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, 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
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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