Medtronic's next-gen leadless pacemakers score FDA approval

Medtronic has secured the FDA’s approval for the latest generation of its miniaturized, wireless pacemaker implants, the Micra AV2 and VR2. 

According to the company, the newest models can offer up to 40% more battery life over their predecessors—boosting them out to 16 and 17 years, respectively—and making them a more attractive option for comparatively younger patients while requiring fewer replacement procedures. In fact, Medtronic estimates that the time span will cover more than 80% of the patients who receive pacemaker implants.

Compared to traditional pacemakers, the Micra is less than a tenth the size and weighs less than 2 grams, comparable to a small capsule. While past implants have been placed under the skin near the collarbone and wired into the cardiac muscle with small leads, these devices are embedded within the heart’s chambers through a minimally invasive procedure.

The previous Micra AV—first approved in 2020, and designed for dual-chamber use in the heart’s atrium and ventricle—had a battery life rated between eight and 13 years. The single-chamber Micra VR, meanwhile, could last nearly 14 years.

The new Micra AV2 also includes motion sensors and updated algorithms that can help it automatically sync up with the heart’s two-step contractions—requiring fewer clinic visits for device programming—while also being able to track faster heartbeats in more active users.

"Our goal is to improve the patient experience by continuously reinventing our ground-breaking leadless pacemaker," Robert Kowal, general manager of Medtronic’s cardiac pacing therapies unit, said in a release, adding that nearly 200,000 Micra devices have been implanted to date worldwide.