Medtronic has received the CE mark for its Micra AV2 and Micra VR2 miniature, leadless pacemakers.
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stamp signalling approval
The company says Micra AV2 and Micra VR2 are the world's smallest pacemakers, can provide longer battery life and easier programming than prior Micra pacemakers, while delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.
With approximately 40% more battery life compared to previous generations, Medtronic projects the battery life of Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively. This means more than 80% of patients who receive a Micra may only require one device for life.
This CE mark follows U.S. Food and Drug Administration approval for the Micra AV2 and VR2 devices in 2023.
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.
Robert C. Kowal, general manager, Cardiac Pacing Therapies within the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic, said: "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.”
Dr. Christophe Garweg, cardiologist at University Hospitals of Leuven, Belgium, added: "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 optimise AV synchrony at faster heart rates while requiring less in-office programming. These advantages likely will expand the use of the leadless pacemaker to more patients."
