GALWAY, Ireland – October 19 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that its Vitalis™ portfolio of cardiac devices – ReSyncra CSP™, Restoria CSP™, Refina CSP™, Effectra™, and Confirma™ pacemakers – has received CE Mark. Together, these pacemakers offer a comprehensive suite of pacing options that include advanced features purpose-built for conduction system pacing (CSP) therapy.

“Our new pacemakers build on Medtronic's long history of leadership in cardiac electrophysiology therapies,” said Robert C. Kowal, M.D., Ph.D., general manager, Cardiac Pacing Therapies within the Medtronic Electrophysiology Therapies operating unit. "From patients requiring traditional pacing support to those who may benefit from conduction system pacing or cardiac resynchronization therapy, this portfolio was designed to personalize therapy, simplify physician workflows, and support patients throughout their healthcare journey."

Conduction system pacing (CSP) taps directly into the heart's natural electrical pathways to help regulate both heart rate and heartbeat coordination simultaneously, delivering a more physiologic pacing option for patients.

The ReSyncra CSP pacemaker, the most advanced device in the new portfolio, introduces a new treatment option for patients who may benefit from cardiac resynchronization therapy (CRT) and are indicated for a conventional biventricular pacemaker, but for whom effective CRT cannot be achieved. Traditional CRT attempts to restore coordination between the right and left sides of the heart by pacing both ventricles. Instead of relying solely on traditional biventricular pacing, the ReSyncra CSP pacemaker leverages CSP to help improve ventricular synchronization.

Additional Medtronic innovations across the new portfolio of pacemakers include:

• Advanced pacing algorithms tailored to patient needs, including the CSP MVP™ feature in ReSyncra CSP, Restoria CSP, and Refina CSP dual-chamber pacemakers, which provides additional options to personalize pacing therapy, and the AdaptivCSP™ feature available only in ReSyncra CSP pacemakers, which automatically adjusts pacing timing to help optimize heart synchrony for patients with heart failure in whom effective CRT cannot be achieved.
• Advanced remote and in-office monitoring capabilities with ReSyncra CSP, Restoria CSP, and Refina CSP pacemakers through the CSP Morphology Monitor™ feature, which provides clinicians with the ability to monitor CSP therapy over the course of a patient’s treatment.
• First-in-industry RadiaSure™ technology, which can help patients safely tolerate the radiation dose associated with nearly all cancer treatments. Medtronic is the only pacemaker manufacturer to specify a safe radiation dose for its devices.
• An Allometric Pacing™ feature, which enables physicians to personalize pacing rates based on characteristics such as a patient’s height and ejection fraction (a measure of how well the heart pumps blood).
• Day Zero MRI, which allows patients to undergo MRI scans immediately after implant, without waiting the traditional four-to-six-week period.

Alongside the comprehensive suite of Medtronic tools to support CSP procedures, including the lumenless SelectSecure™ MRI SureScan™ Model 3830 pacing lead, the C320LBB delivery system for targeted lead placement, and the Medtronic rotatable connector 5944RL accessory for continuous signal monitoring during implantation, the approval of this new portfolio of pacemakers expands access to pacing technology specially designed for conduction system pacing.

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 95,000+ 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.com and follow Medtronic on 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.

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ii Schaller, R. D., Foley, P., Chandrasekaran, B., Lyne, J., Jastrzębski, M., Vijayaraman, P., Upadhyay, G. A., Gardas, R., Richardson, T., Kudlik, D., Stadler, R. W., Zimmerman, P., Burrell, J., Waxman, R., Cornelussen, R. N., Herweg, B., & Whinnett, Z. (2026). Optimal pace timing for left bundle branch area pacing with or without an additional LV lead: Results from the CSPOT study. Europace, 28, euag103. https://doi.org/10.1093/europace/euag103
iii V&V testing, Medtronic data on file.
iv D01541333_B Project Bolt CSP Morphology Monitor Algorithm Performance Evaluation. Medtronic data on file.
v E. Johnson Review and Analysis from Karimzad K, Shah S, Kry SF, et al. Safety of Contemporary Radiation Therapy in Patients With Cardiac Implantable Electronic Devices: Implications for Clinical Practice. J Am Heart Assoc. 2025;14(17):e042937. Medtronic data on file. doi:10.1161/JAHA.125.042937
vi Radiation comparison of Medtronic pacemakers versus other commercially available pacemakers. Medtronic data on file. 2026.
vii Infeld M, Wahlberg K, Cicero J, et al. Effect of personalized accelerated pacing on quality of life, physical activity, and atrial fibrillation in patients with preclinical and overt heart failure with preserved ejection fraction: The myPACE randomized clinical trial. JAMA Cardiol. 2023;8(3):247–257. doi:10.1001/jamacardio.2023.0156
viii R26004 - MRI Hazard Evaluation Summary for Vitalis family of MRI SureScan Systems. Medtronic data on file.