Medtronic’s Micra AV2 and VR2 Leadless Pacemakers Approved by FDA

May 1, 2023—Medtronic plc announced it has received FDA approval for its Micra AV2 and Micra VR2, the next generation of the company’s miniaturized, leadless pacemakers. Less than one-tenth the size of traditional pacemakers, Micra pacemakers are comparable in size to a multivitamin.

According to the company, Micra AV2 and Micra VR2 provide longer battery life and easier programming than previous Micra pacemakers, while delivering the 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. The median projected battery life is approximately 16 years for Micra AV2 and 17 years for Micra VR2. More than 80% of patients who receive a Micra are projected to only need one device for life, noted the company.

The Micra AV2 includes advanced algorithms that automatically program AV synchrony, thereby coordinating the heart’s upper and lower chambers. Additionally, for patients who are active, Micra AV2 has a higher available tracking capability for faster heart rates (increased from 115 to 135 beats per minute for upper limits).

“Improved AV synchrony—requiring less in-office reprogramming thanks to algorithm optimization—and longer battery life are major wins for patients,” commented Camille Frazier-Mills, MD, in Medtronic’s press release.

Dr. Mills, who is an electrophysiologist at Duke University Health System in Durham, North Carolina, continued, “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.”