Dublin, Ireland- January 2024- The CE (Conformité Européenne) Mark approval for the MicraTM AV2 and MicraTM VR2 by Medtronic plc, a prominent player in the healthcare technology industry, represents a major advancement in the field of small, leadless pacemakers to come.
These newly approved devices, Micra AV2 and Micra VR2, are recognized as the world’s smallest pacemakers. They come with improved battery life and simpler programming compared to their predecessors while maintaining the benefits of leadless pacing, known for reducing complications associated with traditional pacemakers.
The enhancements in Micra AV2 and Micra VR2 include an impressive 40% increase in battery life compared to earlier models. Medtronic estimates that the battery life for Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively. This means that a significant majority of patients receiving a Micra pacemaker may only need a single device for their entire life.
This achievement follows the approval of the Micra AV2 and VR2 devices by the U.S. Food and Drug Administration in 2023.
In addition to their compact size and extended longevity, Micra devices stand out as the only leadless pacemakers equipped with remote monitoring capabilities. This feature enables healthcare providers to monitor a patient’s heart device remotely, eliminating the need for in-person appointments. The advantages of remote monitoring may extend to a reduction in hospitalizations and an increased sense of security for patients.
“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.”
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Micra pacemakers have been implanted in more than 200,000 patients worldwide, demonstrating their effectiveness. They are smaller than a tenth of the size of conventional pacemakers, roughly equivalent in size to a big vitamin. Micra pacemakers remove possible risks connected with leads and pockets by not requiring them, and their discrete design makes them inconspicuous beneath the skin. They also don’t require a surgical “pocket” beneath the skin.
