Results Presented at ESC 2021 Show Micra TPS Compares
Favorably to Traditional Pacemakers
DUBLIN, Aug. 27, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced new data from the Micra Coverage with Evidence
Development (CED) Study, the largest evaluation of leadless
pacemakers to date, which showed the Micra™ Transcatheter
Pacing System (TPS) was associated with a 38% reduction in
reinterventions and a 31% reduction in chronic complications at
2-years compared with traditional transvenous (TV-VVI) pacemakers.
The data were presented virtually today in a late-breaking trials
presentation at the European Society of Cardiology (ESC) Congress
2021.
"There is considerable evidence supporting the safety and
efficacy of leadless pacemakers, but limited data evaluating their
long-term outcomes compared to traditional pacemakers in a
real-world setting," said Jonathan P.
Piccini, M.D., associate professor of medicine and director
of cardiac electrophysiology at Duke
University Medical Center. "The results from this study
further support the connection of a lower risk of complications
with leadless pacing compared with traditional transvenous single
chamber pacing. These data should help guide physicians as they
determine the best pacing options for their patients."
The Micra CED study is a continuously enrolling, observational,
cohort study evaluating claims-based complications, utilization and
outcomes of Micra TPS in the U.S. Medicare fee-for-service
population. It is the first study to use Centers for Medicare &
Medicaid Services (CMS) administrative claims data to evaluate
clinical outcomes of leadless pacing in the real-world setting and
compare outcomes to a contemporaneous cohort of patients implanted
with transvenous-VVI pacemakers.
The CED study used statistical adjustment to account for
differences in patient characteristics at baseline. Although Micra
patients had more co-morbidities than transvenous VVI patients, the
adjusted results showed patients with Micra had significantly fewer
reinterventions compared to patients with TV-VVI devices (Micra
3.1% vs. TV-VVI 4.9%; adj. P=0.003) including significantly fewer
system revisions, device removals, and upgrades to cardiac
resynchronization therapy. Micra TPS patients also had
significantly fewer chronic complications at 2-years (Micra 4.6% vs
TV-VVI 6.5%; adj. HR 0.69, 95% CI: 0.60-0.81, P<0.0001).
Although Micra patients had more comorbidities than transvenous-VVI
patients, there was no difference in adjusted all-cause
mortality at 2-years compared to the transvenous comparator
population (adj. HR 0.97, 95% CI 0.91-1.04, P=0.37).
Researchers evaluated 6,219 patients implanted with Micra VR TPS
and 10,212 patients implanted with traditional TV-VVI pacemakers;
they compared system reinterventions, chronic complications, and
all-cause mortality at 2-years after implant. Overall, patients
implanted with Micra TPS were sicker (with a greater comorbidity
burden) than TV-VVI patients, with higher rates of end stage renal
disease (ESRD) (12.0% vs. 2.3%) and renal dysfunction (48.8% vs.
42.1%), and a higher Charlson Comorbidity Index score (5.1 vs.
4.6).
"As part of our commitment to improving outcomes for patients
needing pacing therapy, we embraced the opportunity to evaluate our
devices in a real-world setting," said Rob
Kowal, M.D., Ph.D., chief medical officer of the Cardiac
Rhythm Management business, which is part of the Cardiovascular
Portfolio at Medtronic. "The results presented at ESC further
reinforce the significant advantages of leadless pacemakers and
support earlier findings that show a reduced risk of complications
with Micra TPS. These data should assist physicians and patients to
select the most appropriate, individualized pacing option to meet
their goals."
Micra TPS is the only leadless pacing system available globally.
Recently, Medtronic announced that more than 100,000 patients
have received a Micra device worldwide.
About the Micra Transcatheter Pacing System
(TPS)
Micra TPS is a leadless pacemaker option for patients
who only require pacing in the right ventricle. Comparable in size
to a large vitamin, Micra is less than one-tenth the size of
traditional pacemakers yet delivers advanced pacing technology to
patients via a minimally invasive approach. During the implant
procedure, the device 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, Micra does not require leads or a
surgical "pocket" under the skin, so potential sources of
complications related to leads and pockets are eliminated - as are
any visible signs of the device.
Micra received CE Mark in 2015 and was approved by the FDA in
2016.
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.
Medtronic strives to offer products and services of the highest
quality 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 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 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 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.
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SOURCE Medtronic plc