The Medtronic Micra™
Transcatheter Pacing System (TPS) is the First Leadless
Pacemaker Licenced in Canada
BRAMPTON, ON, Oct. 22, 2016 /CNW/ - Medtronic Canada, a
subsidiary of Medtronic plc (NYSE:MDT), today announced it has
received a Health Canada licence for the world's smallest
pacemaker, the Medtronic Micra™ Transcatheter Pacing System (TPS).
The Micra TPS is the first Health Canada licenced 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 need for cardiac wires
(leads).
Comparable in size to a large vitamin capsule, 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, and there are
no visible signs of the device. The Micra TPS responds to patients'
activity levels by automatically adjusting therapy.
Micra TPS is the first and only leadless pacing system to be
licenced for both 1.5 and 3 Tesla (T) full-body magnetic resonance
imaging (MRI) scans, providing patients with continued access to
these advanced imaging diagnostic procedures.
The Micra design incorporates a retrieval feature to enable
repositioning if needed; 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 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, which included two
Canadian centres, were published in the New England Journal of
Medicine and presented during a late-breaking Special Report at
the American Heart Association Scientific Sessions. These 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 at six month
follow-up.
Data presented in August 2016 at
the European Society of Cardiology (ESC) Congress showed that the
risk for major complications with the Micra TPS remained
consistently low, with 96 percent of patients experiencing no major
complications through 12 months follow-up (95 percent confidence
interval, 94.2 percent-97.2 percent, P<0.0001). The Micra TPS
reduced the risk of major complications by nearly half (48 percent;
hazard ratio = 0.52, P=0.001) compared to conventional systems and
the risk was lower across all patient sub-groups, whether measured
by age, sex or comorbidity (all hazard ratios < 1.0).
The overall reduction in major complications with the Micra TPS
was associated with a 47 percent decrease (p=0.017) in the risk of
hospitalization and 82 percent (p<0.001) reduction in risk of
system revisions (meaning extraction, repositioning or replacement)
compared to conventional pacing systems.
"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 Michael
Blackwell, director of the CardioVascular Group at Medtronic
Canada. "We are thrilled to be the first to introduce a
transcatheter pacemaker to patients in Canada, 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 and FDA approval in April 2016. 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 in the near
future.
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers one of the broadest ranges
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.
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About Medtronic
Medtronic Canada (www.medtronic.ca),
headquartered in Brampton, Ontario
is a subsidiary of Medtronic plc, which 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 is proud to employ over 1,600
people in Canada, serving
physicians, hospitals and patients across the country. 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.
SOURCE Medtronic Canada