The Medtronic
Micra® TPS is the First Transcatheter Pacemaker Approved in the
U.S.
Gives Patients
Access to the Most Advanced Pacing Technology at One-Tenth the Size
of Traditional Devices
DUBLIN - April 6, 2016 -
Medtronic plc (NYSE:MDT) today announced it has received U.S. Food
and Drug Administration (FDA) approval of the world's smallest
pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS).
The Micra TPS is the first FDA-approved product with miniaturized
pacing technology. It is cosmetically invisible and small enough to
be delivered through a catheter and implanted directly into the
heart -providing a safe alternative to conventional pacemakers
without the complications associated with cardiac wires
(leads).
"For many years we've been hopeful that a
transcatheter pacing solution - with a safety and effectiveness
profile on par with conventional devices - would become available,
and today Micra has achieved this milestone," said Dwight Reynolds,
M.D., regent's professor and chief of the Cardiovascular Section at
the University of Oklahoma Health Sciences Center, and principal
investigator in the Micra TPS Global Clinical Trial. "In the
clinical trial, the Micra was successfully implanted in nearly all
patients, and met its safety and effectiveness endpoints by wide
margins. This gives us great confidence that this miniaturized
device will bring patients the most advanced pacing technology,
combined with the less-invasive nature of the new technology."
Comparable in size to a large vitamin, the Micra
TPS is attached to the heart with 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 related to such leads and pocket
are eliminated-as are any visible signs of the device. The device
responds to patients' activity levels by automatically adjusting
therapy.
Micra TPS is the first and only transcatheter
pacing system to be approved for both 1.5 and 3 Tesla (T) full-body
magnetic resonance imaging (MRI) scans, providing patients with
access to the most advanced imaging diagnostic procedures
available.
The Micra design incorporates a retrieval feature
to enable retrieval when possible; however, the device is designed
to be left in the body. For patients who need more than one device,
the miniaturized Micra TPS was designed with a unique feature that
enables it to be permanently turned off so it can remain in the
body and a new device can be implanted without risk of electrical
interaction.
In November 2015, data from the Medtronic Micra
TPS Global Clinical Trial were published in the New England Journal of Medicine and presented during a
late-breaking Special Report at the American Heart Association
Scientific Sessions. Data showed the Micra TPS was successfully
implanted in 99.2 percent of patients, there were no (0)
dislodgements, and the system met its safety and effectiveness
endpoints with wide margins.
In the Micra trial, 96 percent of patients (700 of
725; six-month Kaplan-Meier estimate) experienced no major
complications, which is significantly fewer - 51 percent fewer -
major complications than seen in patients with conventional pacing
systems (hazard ratio: 0.49; 95 percent CI, 0.33 to 0.75; P=0.001).
Major complications included cardiac injuries (1.6 percent),
complications at the groin site (0.7 percent) and pacing issues
(0.3 percent).
Almost all patients, 98.3 percent (292 of 297),
had low and stable pacing thresholds at six months, yielding
projected average longevity for the device of more than 12
years.
In addition, the low major complication rates
experienced by Micra patients resulted in significant reductions in
healthcare utilization compared to conventional pacing systems:
Micra patients had 54 percent fewer hospitalizations (p=0.011) and
87 percent fewer system revisions (p<0.001) than observed in the
historical control group.
The trial enrolled 744 patients; it evaluated the
safety and efficacy of the device through a single-arm,
multi-center study at 56 centers in 19 countries. Primary endpoints
of the trial were freedom from device-related or procedure-related
major complications with target performance of >90 percent
(lower CI >83 percent) at six months, and low and stable pacing
thresholds as demonstrated by <= 2V and no increase of >1.5V
(relative to implant) and target performance of >89 percent
(lower CI >80 percent) in the first 300 patients at six
months.
"Dating back to the development of the first
external battery operated pacemaker more than 60 years ago,
Medtronic has a long history of collaborating with clinicians to
better understand the needs of patients, and then innovating new
products to meet those needs," said John Liddicoat, M.D., senior
vice president, Medtronic, and president of the Cardiac Rhythm and
Heart Failure division. "We are thrilled to be the first to
introduce a transcatheter pacemaker to patients in the U.S., and
we're looking forward to working with physicians and educating
implanters to extend the positive results of our global clinical
trial experience to even more patients."
The Micra TPS was awarded CE Mark in April 2015
based on early data from the Medtronic Micra TPS Global Clinical
Trial. It is intended for use in patients who need a single-chamber
pacemaker. The device was designed to allow patients to be followed
by their physicians and send data remotely via the Medtronic
CareLink® Network;
remote monitoring of Micra devices is expected to be available
later this year.
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.
Multimedia Release
A multimedia version of this release with a patient story,
animation and downloadable graphics can be found at:
http://bit.ly/1SwDGpX
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
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-
Contacts:
Ryan Mathre
Public Relations
+1-763-514-9625
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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