New pacemakers offer 40% more battery
life,1 extend Medtronic legacy of pacing
leadership
DUBLIN, Jan. 5, 2024
/PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in
healthcare technology, today announced it has received CE
(Conformité Européenne) Mark for its Micra™ AV2 and Micra™ VR2, the
next generation of its industry-leading miniature, leadless
pacemakers.
Micra AV2 and Micra VR2, the world's smallest pacemakers,
provide longer battery life and easier programming than prior Micra
pacemakers, while still delivering the many benefits of leadless
pacing such as reduced complications compared to traditional
pacemakers.2
With approximately 40% more battery life compared to previous
generations,1 Medtronic projects the battery life of
Micra AV2 and Micra VR2 is nearly 16 and 17 years,
respectively.3 This means more than 80% of patients who
receive a Micra may only require one device for
life.3
This CE Mark milestone follows U.S. Food and Drug Administration
approval for the Micra AV2 and VR2 devices in 2023.
In addition to size and longevity benefits, Micra devices are
also the only leadless pacemakers with remote monitoring
capabilities, which allow a doctor or clinic to check on a
patient's heart device without the need for a patient to travel to
their clinic for an in-person appointment. Other patient
benefits of remote monitoring may include a reduction in
hospitalizations and increase in sense of
security.4,5
"For more than eight years, our Micra leadless pacemakers have
provided meaningful benefits to people in Europe who require a pacemaker. Now, these
patients have access to the latest leadless pacing technology that,
for most of them, may be the only device they will ever need," said
Robert C. Kowal, M.D., Ph.D.,
general manager, Cardiac Pacing Therapies within the Cardiac Rhythm
Management business, which is part of the Cardiovascular Portfolio
at Medtronic.
"The first generation of leadless Micra pacemakers demonstrated
a significant reduction in major complications, and this next
generation of Micra brings several additional benefits including
greater longevity, and specifically for the Micra AV2, new
algorithms to optimize AV synchrony at faster heart rates while
requiring less in-office programming," said Prof. Dr. Christophe
Garweg, Cardiologist at University Hospitals of Leuven,
Belgium. "These advantages likely
will expand the use of the leadless pacemaker to more
patients."
Globally, more than 200,000 patients have received Micra
pacemakers.6 Comparable in size to a large vitamin,
Micra pacemakers are less than one-tenth the size of traditional
pacemakers. Unlike traditional pacemakers, Micra pacemakers do not
require leads or a surgical "pocket" under the skin, so potential
sources of complications related to leads and pockets are
eliminated, and there is no visible sign of the device.
Leaders in Cardiac Pacing
Receiving CE Mark for Micra
AV2 and VR2 builds on the Medtronic legacy in cardiac pacing, which
includes:
- Inventing the first wearable pacemaker in 1957.
- Launching the first pacemaker for use in MRIs in
2011.
- Creating and launching the first leadless pacemaker in
2015.
- Launching the first leadless pacemaker to coordinate the
heart's electrical signals by sensing atrial activity, without a
lead or device in the atria, in 2020.
- Gaining regulatory approval for the first pacing system to
activate the heart's natural electrical system, conduction system
pacing (approval via the His-bundle in 2018 and via the left bundle
branch area in 2022).
- Receiving U.S. approval for Micra AV2 and VR2 in
2023.
About Medtronic
Bold thinking. Bolder actions. We are
Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global
healthcare technology company that boldly attacks the most
challenging health problems facing humanity by searching out and
finding solutions. Our Mission — to alleviate pain, restore health,
and extend life — unites a global team of 90,000+ passionate people
across more than 150 countries. Our technologies and therapies
treat 70 health conditions and include cardiac devices, surgical
robotics, insulin pumps, surgical tools, patient monitoring
systems, and more. Powered by our diverse knowledge, insatiable
curiosity, and desire to help all those who need it, we deliver
innovative technologies that transform the lives of two people
every second, every hour, every day. Expect more from us as we
empower insight-driven care, experiences that put people first, and
better outcomes for our world. In everything we do, we are
engineering the extraordinary. For more information on Medtronic
(NYSE:MDT), visit www.Medtronic.com and LinkedIn.
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.
References:
1 Escalante K. Micra AV2 and Micra VR2 longevity
comparison. 2023. Medtronic Data on File.
2 El-Chami MF, Al-Samadi F, Clementy N, et al.
Updated performance of the Micra transcatheter pacemaker in the
real-world setting: A comparison to the investigational study and a
transvenous historical control. Heart Rhythm. December 2018;15(12):1800-1807.
3 Sheldon T, Escalante K, and Fagan D. Device
Longevity and AV Synchrony Algorithm Modeling of a Leadless
Pacemaker Family: A Virtual Patient Analysis. January 2023. Medtronic Data on File.
4 Piccini JP, Mittal S, Snell J, Prillinger JB,
Dalal N, Varma N. Impact of remote monitoring on clinical events
and associated health care utilization: A nationwide assessment.
Heart Rhythm. 2016 Dec;13(12):2279-2286. doi:
10.1016/j.hrthm.2016.08.024. Epub 2016 Aug 17. PMID: 27544748.
5 Artico J, Zecchin M, Fantasia AZ, Skerl G,
Ortis B, Franco S, Albani S, Barbati G, Cristallini J, Sinagra G.
Long-term patient satisfaction with implanted device remote
monitoring: a comparison among different systems. Journal of
Cardiovascular Medicine. 2019 Aug
1;20(8):542-50.
6 Leick, A. Micra "Largest Reach" supporting data.
September 2023. Medtronic Data on
file.
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SOURCE Medtronic plc