Medtronic’s Micra AV2 and VR2 Leadless Pacing Systems Receive CE Mark Approval

January 5, 2024—Medtronic announced it has received European CE Mark approval for Micra AV2 and Micra VR2, the company’s next-generation miniature, leadless pacemakers.

On May 1, 2023, the company announced FDA approval for the Micra AV2 and VR2 devices in the United States.

According to the company, Micra AV2 and Micra VR2 provide longer battery life and easier programming than previous Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.

The new devices offer approximately 40% more battery life compared to previous generations. Medtronic projects the battery life of Micra AV2 and Micra VR2 to be nearly 16 and 17 years, respectively, so that more than 80% of patients who receive a Micra may only require one device for life, noted the company.

Medtronic’s Micra pacemakers, which are comparable in size to a large vitamin, are less than one-tenth the size of traditional pacemakers. They do not require leads or a surgical pocket under the skin, eliminating these sources of potential complications.

In addition to size and longevity benefits, Micra devices offer 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. Remote monitoring may reduce hospitalizations and increase in sense of security, stated the company.

“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,” commented Professor Christophe Garweg, MD, in Medtronic’s press release. “These advantages likely will expand the use of the leadless pacemaker to more patients.” Prof. Garweg is a cardiologist at University Hospitals of Leuven, Belgium.