Medtronic's Next-Gen Miniaturized Pacemakers Receive FDA Approval

Medical technology company Medtronic has received approval from the US Food and Drug Administration (FDA) for its next generation of miniaturized, leadless pacemakers. The Micra AV2 and Micra VR2 are the world’s smallest pacemakers, offering longer battery life and easier programming than previous generations.

According to Medtronic, the Micra AV2 and Micra VR2 provide approximately 40% more battery life than previous generations, with a median projected battery life of nearly 16 and 17 years, respectively. This means that more than 80% of patients who receive a Micra pacemaker are projected to only need one device for life.

The Micra AV2 also features advanced algorithms that automatically program AV synchrony, which coordinates the heart’s upper and lower chambers. Additionally, for active patients, the Micra AV2 has a higher available tracking capability for faster heart rates, increased from 115 to 135 beats per minute for upper limits.

Dr. Camille Frazier-Mills, an electrophysiologist at Duke University Health System, stated that “improved AV synchrony – requiring less in-office reprogramming thanks to algorithm optimization – and longer battery life are major wins for patients.” She expressed excitement in offering her patients the new Micra devices, which eliminate potential complications related to leads and pockets, and reduce the chance that patients will need their device changed in the future.

Medtronic’s Micra pacemakers are less than one-tenth the size of traditional pacemakers and do not require leads or a surgical “pocket” under the skin. This eliminates potential sources of complications related to leads and pockets, and there is no visible sign of the device.

This FDA approval builds on Medtronic’s legacy in cardiac pacing, including inventing the first wearable pacemaker in 1957, launching the first pacemaker for use in MRIs in 2011, and creating and launching the first leadless pacemaker in 2015.

Since then, Medtronic has continued to transform pacing technologies to benefit patients, including gaining regulatory approval for the first pacing system to activate the heart’s natural electrical system, conduction system pacing. The His-bundle approval was granted in 2018, and the left bundle branch area approval in 2022.

The Micra pacemakers have been well-received globally, with nearly 200,000 patients having received the devices so far. Medtronic’s goal is to continuously reinvent their leadless pacemakers to improve the patient experience.