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Medtronic, a worldwide leader in healthcare technology, made the announcement that it has gained clearance from the U.S. Food and Drug Administration (FDA) for its Micra AV2 and Micra VR2 pacemakers. These Leadless PaceMakers are the newest generation of the company’s industry-leading miniaturized, leadless pacemakers.
The Advantages of the Micra AV2 and Micra VR2 Leadless Pacemakers:
- Touted as the world’s smallest pacemakers
- Have a longer battery life than previous versions
- Are reportedly easier to set up than their predecessors
- Have fewer complications in comparison to traditional pacemakers
The median anticipated battery life for the Micra AV2 is roughly 16 years, while for the Micra VR2, it is about 17 years. This represents an increase in battery life of around 40% when compared to the battery life of the preceding generation. Because of this, it is anticipated that more than 80% of individuals who are given a Micra will only require one device for the rest of their lives.
In addition, the new Micra AV2 has cutting-edge algorithms that automatically configure AV synchronization, therefore synchronizing the functions of the upper and lower chambers of the heart. Additionally, the Micra AV2 has a larger accessible tracking capability for faster heart rates, making it more suitable for patients who lead active lifestyles; the upper limit for beats per minute has been increased from 115 to 135.
Camille Frazier-Mills, an electrophysiologist at Duke University Health System, stated, “Improved AV synchrony – requiring less in-office reprogramming thanks to algorithm optimization – and longer battery life are major wins for patients. I’m excited to offer my patients the new Micra devices. This best-in-class technology transforms the patient experience by eliminating pocket-related complications, and now reduces the chance that patients will need their device changed in the future.”
Cardiac Pacing Therapies’ Vice President and General Manager Robert Kowal have stated that the firm places a high priority on improving the patient experience via the development of new iterations of the revolutionary leadless pacemaker. Medtronic has revolutionized pacing technology for the benefit of patients over the past 65 years, beginning with the invention of the first battery-operated cardiac pacemakers. To date, almost 200,000 people all around the world have been fitted with a Micra device.
Micra pacemakers are significantly smaller, with their size being less than a tenth of the size of conventional pacemakers. They eliminate the need for leads or a surgical “pocket” beneath the skin, so they are almost undetectable and do not provide any additional risk of problems.
Despite the fact that advocates of leadless pacemakers claim their devices are inherently safer than conventional pacemakers, there is still a possibility of adverse effects from using leadless pacemakers.
In a letter that was sent in 2021, the FDA warned doctors about the potential for serious problems in the event that cardiac perforation occurs during the implantation of a leadless pacemaker. A cardiac perforation can occur during the insertion of any type of pacemaker, and the overall risk appears to be comparable for leadless and standard pacing systems, according to the FDA.
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