Medtronic Nabs CE Mark for Micra AV2 and Micra VR2 Leadless Pacemakers

Dublin medtech giant, Medtronic, today announced its Micra AV2 and Micra VR2 next generation miniature leadless pacemakers, which obtained FDA approval in 2023, have now also received a CE mark.

The leadless pacemakers are touted as the world’s smallest for bradyarrhythmia management at the size of a large vitamin and forgo the need to for leads or a surgical “pocket” under the skin. This departure from traditional pacemakers eliminates potential sources of complications and shows no visible sign that a patient has a device implanted.

The company’s original version, called the Micra, was the first leadless pacemaker to receive FDA approval in 2016, representing a major win over competitors at the time like St. Jude Medical (which was acquired by Abbott in 2017). Implanted directly into the heart using a steerable catheter, the original device boasted a battery life of 12 years.

The newly FDA and CE-approved Micra AV2 and Micra VR2 have improved battery life projections by approximately 40% to nearly 16 and 17 years, respectively, meaning that more than 80% of patients who receive a device will only require one for life. Along with the size and battery life benefits, according to Medtronic, the Micra AV2 and VR2 devices come with remote monitoring capabilities that allow for healthcare providers to check on a patient’s device without the need for an in-person appointment.

As previously reported by MD+DI when the devices obtained FDA approval, the AV2 also includes “advanced algorithms that automatically program AV synchrony, thereby coordinating the heart's upper and lower chambers. Also, for patients who are active, Medtronic said the Micra AV2 has a higher available tracking capability for faster heart rates (increased from 115 to 135 beats per minute for upper limits).”

The company was the only FDA approved leadless pacemaker for years until Abbott won FDA approval for its Aveir VR device in 2022. The Aveir device is implanted directly in the left ventricle via a minimally invasive procedure and is designed with a mapping capability that allows physicians to measure electrical signals with the heart to determine correct placement before final implantation. Abbott also noted that the device is designed to be retrieved if therapy needs evolve.

Before Abbott’s big win, Medtronic had a long history of outpacing competition in the space. In fact, Medtronic invented the first wearable pacemaker in 1957; launched the first pacemaker safe for use in MRIs in 2011; launched Micra in Europe in 2015 – US in 2016; launched the first leadless pacemaker designed to coordinate the heart’s electrical signals by sensing atrial activity, without a lead or device in the atria, in 2020; and gained regulatory approval for the first pacing system to activate the heart’s natural electrical system, conduction system pacing (approval via the His-bundle in 2018 and via the left bundle branch area in 2022), according to Amanda Pedersen, in previous reporting for MD+DI.

While Medtronic and Abbott remain at the forefront, Boston Scientific continues to conduct research on its mCRM system leadless defibrillator and pacemaker. The company initiated a clinical trial in December 2021 for the system, which has two cardiac rhythm management devices intended to work together to coordinate therapy. If FDA approved, the mCRM device would be the first leadless pacemaker capable of delivering bradycardia pacing support and antitachycardia pacing.