Nov 20, 2024

Medtronic receives Health Canada licence for its next generation Micra leadless pacing systems

New pacemakers offer 40% more battery life1, extending Medtronic legacy of pacing leadership

Medtronic plc, a global leader in healthcare technology, is announcing it has received a Health Canada licence for its Micra™ AV2 and Micra™ VR2 Transcatheter Pacing System, the next generation of its industry-leading miniature, leadless pacemakers.

Micra AV2 and Micra VR2, the world's smallest pacemakers,7 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

In addition to size and longevity benefits, Micra devices have 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 Canada 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 Rob Clifton, President, Medtronic Canada.

"The first generation of leadless Micra pacemakers is an interesting non-transvenous pacing solution for patients which has shown a significant decrease in major complications,” shares Dr. Blandine Mondésert, Clinical Associate Professor Department of Medicine, University of Montréal, Cardiac electrophysiology service Adult Congenital Heart Disease Center, Montreal Heart Institute. “This next generation of Micra brings several additional benefits, such as greater longevity, and specifically for the Micra AV2, new algorithms to optimize AV synchrony at faster heart rates while requiring less in-office programming. I am looking forward to expanding the use of the leadless pacemaker to more of my patients.”

Comparable in size to a large vitamin, Micra pacemakers are less than one-tenth the size of traditional pacemakers. And 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.

"Our goal is to improve the patient experience by continuously reinventing our ground-breaking leadless pacemaker," adds Clifton. "Since inventing the first battery-operated cardiac pacemakers over 65 years ago, Medtronic has transformed pacing technologies to benefit patients, including the nearly 200,000 patients globally6 who have received a Micra device so far."

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, 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, visit Medtronic.ca 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.
Leick, A. Micra "Largest Reach" supporting data. September 2023. Medtronic Data on file.
7 Leick A. Micra vs Leadless and Transvenous Pacemaker Size Comparison. March 2023. Medtronic data on file.

Contacts:
Monika Paquette
Public Relations
+1-416-579-2823

Ryan Weispfenning
Investor Relations
+1-763-505-4626