Medtronic receives US FDA approval for latest Micra leadless pacemakers

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Medtronic has received US Food and Drug Administration (FDA) approval of its Micra AV2 and Micra VR2 leadless pacemakers.

Micra AV2 and Micra VR2, the world’s smallest pacemakers, 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, Medtronic says in a press release.

The company states that with 40% more battery life compared to previous generations, the median projected battery life of Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively. This, it says, means more than 80% of patients who receive a Micra are projected to only need one device for life.

The new Micra AV2 also includes advanced algorithms that automatically program AV synchrony, thereby coordinating the heart’s upper and lower chambers.

“Improved AV synchrony—requiring less in-office reprogramming thanks to algorithm optimisation—and longer battery life are major wins for patients,” said Camille Frazier-Mills (Duke University Health System, Durham, USA). “I am 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.”


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