FDA Approves Medtronic's Next Generation Micra Leadless Pacing Systems

The FDA has approved Medtronic plc's MDT Micra AV2 and Micra VR2, the next generation of its miniaturized, leadless pacemakers.

The company says Micra AV2 and Micra VR2, the world's smallest pacemakers, provide longer battery life and easier programming than prior Micra pacemakers.

With approximately 40% more battery life than previous generations, the median projected 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 are projected to only need one device for life.

The new Micra AV2 also includes advanced algorithms that automatically program AV synchrony, coordinating the heart's upper and lower chambers. 

Also, for active patients, Micra AV2 has a higher available tracking capability for faster heart rates (increased from 115 to 135 beats per minute for upper limits).

Last week, the FDA approved Medtronic MiniMed 780G system with the Guardian 4 sensor requiring no fingersticks while in SmartGuard technology.

The system is approved for users seven years old and above with type 1 diabetes.

Price Action: MDT shares are down 0.02% at $90.93 on the last check Monday.