Medtronic Receives CE Mark For Its Next Generation Micra Leadless Pacing Systems

Micra™ AV2 and Micra™ VR2

Medtronic plc (NYSE: MDT), a worldwide chief in healthcare know-how, immediately introduced it has obtained CE (Conformité Européenne) Mark for its Micra™ AV2 and Micra™ VR2, the subsequent technology of its industry-leading miniature, leadless pacemakers.

Micra AV2 and Micra VR2, the world’s smallest pacemakers, present longer battery life and simpler programming than prior Micra pacemakers, whereas nonetheless delivering the numerous advantages of leadless pacing similar to decreased problems in comparison with conventional pacemakers.2

With roughly 40% extra battery life in comparison with earlier generations,1 Medtronic initiatives the battery lifetime of Micra AV2 and Micra VR2 is sort of 16 and 17 years, respectively.3 This implies greater than 80% of sufferers who obtain a Micra might solely require one gadget for all times.3

This CE Mark milestone follows U.S. Meals and Drug Administration approval for the Micra AV2 and VR2 units in 2023.

Along with measurement and longevity advantages, Micra units are additionally the one leadless pacemakers with distant monitoring capabilities, which permit a health care provider or clinic to examine on a affected person’s coronary heart gadget with out the necessity for a affected person to journey to their clinic for an in-person appointment. Different affected person advantages of distant monitoring might embrace a discount in hospitalizations and improve in sense of safety.4,5

“For greater than eight years, our Micra leadless pacemakers have offered significant advantages to individuals in Europe who require a pacemaker. Now, these sufferers have entry to the most recent leadless pacing know-how that, for many of them, would be the solely gadget they may ever want,” mentioned Robert C. Kowal, M.D., Ph.D., basic supervisor, Cardiac Pacing Therapies inside the Cardiac Rhythm Administration enterprise, which is a part of the Cardiovascular Portfolio at Medtronic.

“The primary technology of leadless Micra pacemakers demonstrated a big discount in main problems, and this subsequent technology of Micra brings a number of further advantages together with better longevity, and particularly for the Micra AV2, new algorithms to optimize AV synchrony at sooner coronary heart charges whereas requiring much less in-office programming,” mentioned Prof. Dr. Christophe Garweg, Heart specialist at College Hospitals of Leuven, Belgium. “These benefits probably will broaden the usage of the leadless pacemaker to extra sufferers.”

Globally, greater than 200,000 sufferers have obtained Micra pacemakers.6 Comparable in measurement to a big vitamin, Micra pacemakers are lower than one-tenth the scale of conventional pacemakers. In contrast to conventional pacemakers, Micra pacemakers don’t require leads or a surgical “pocket” underneath the pores and skin, so potential sources of problems associated to leads and pockets are eradicated, and there’s no seen signal of the gadget.

Leaders in Cardiac Pacing
Receiving CE Mark for Micra AV2 and VR2 builds on the Medtronic legacy in cardiac pacing, which incorporates:

  1. Inventing the primary wearable pacemaker in 1957.
  2. Launching the primary pacemaker to be used in MRIs in 2011.
  3. Creating and launching the primary leadless pacemaker in 2015.
  4. Launching the primary leadless pacemaker to coordinate the guts’s electrical indicators by sensing atrial exercise, and not using a lead or gadget within the atria, in 2020.
  5. Gaining regulatory approval for the primary pacing system to activate the guts’s pure electrical system, conduction system pacing (approval by way of the His-bundle in 2018 and by way of the left bundle department space in 2022).
  6. Receiving U.S. approval for Micra AV2 and VR2 in 2023.
  7. References:1 Escalante Ok. Micra AV2 and Micra VR2 longevity comparability. 2023. Medtronic Information on File.2 El-Chami MF, Al-Samadi F, Clementy N, et al. Up to date efficiency of the Micra transcatheter pacemaker within the real-world setting: A comparability to the investigational examine and a transvenous historic management. Coronary heart Rhythm. December 2018;15(12):1800-1807.

    3 Sheldon T, Escalante Ok, and Fagan D. Machine Longevity and AV Synchrony Algorithm Modeling of a Leadless Pacemaker Household: A Digital Affected person Evaluation. January 2023. Medtronic Information on File.

    4 Piccini JP, Mittal S, Snell J, Prillinger JB, Dalal N, Varma N. Impression of distant monitoring on medical occasions and related well being care utilization: A nationwide evaluation. Coronary 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. Lengthy-term affected person satisfaction with implanted gadget distant monitoring: a comparability amongst completely different methods. Journal of Cardiovascular Drugs. 2019 Aug 1;20(8):542-50.

    6 Leick, A. Micra “Largest Attain” supporting information. September 2023. Medtronic Information on file.

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