Medtronic, 2nd generation Micra landing shifts the system

Has presented a possibility of a single device for life

Expanded reimbursement for high-risk group…changed patient accessibility to leadless pacemakers

Expansion amid coexistence with transvenous systems…an early phase for a paradigm shift if treatment

Leadless pacemakers are shifting from a 'supplementary technology' to a variable that is fundamentally changing treatment structures in South Korea.

The trend points to a convergence of technological advancements (improved battery life and procedural safety) and institutional changes, such as expanded insurance reimbursement. These factors are transforming access to treatment from a limited scope to a mainstream clinical reality.

Medtronic Korea held a press conference on the 2nd for domestic launch of the 2nd generation Micra (Micra AV2), presenting these significant shifts.

​(From left: Ji Eun Song, Director at Medtronic Korea; Professor Hee Tae Yu, Cardiology, Severance Cardiovascular Hospital; Kangho Park, Marketing Manager at Medtronic Korea)

Battery·Algorithm Improvements…The 2nd Generation Evolution

The presentation explained the new product not merely as a new model, but as a turning point where leadless pacemaker technology, having been clinically validated, moves to its next stage.

Since its introduction in 2015, Micra has been used to treat over 400,000 patients worldwide, accumulating data from 50,000 patients and over 450 studies. 

A 5-year follow-up study showed a major complication rate of approximately 4.5%, with no reported cases of device removal due to infection.

Ji Eun Song, Senior Marketing Director of Cath Lab at Medtronic Korea

Ji Eun Song, Senior Marketing Director of Cath Lab at Medtronic Korea, stated, "We are no longer at the stage of discussing whether the technology is possible. We are now at the stage of considering how far its application can be extended."

The advancements in Micra AV2 can be summarized in three areas: battery, algorithms, and the delivery system.

The most significant change is the battery life. The Micra AV2 lasts approximately 15.6 years and the VR2 approximately 16.7 years, representing improvements of 44% and 36%, respectively.

Song emphasized. "Considering that we mostly have elderly patients, the reported figure indicates 80% of patients can maintain their treatment with a one-time treatment," adding, " This is not just a performance improvement; it is a change that impacts the treatment strategy itself."

We have also improved algorithm. Atrial mechanical sensing has been refined, allowing for stable atrioventricular (AV) synchrony even at high heart rates, with the maximum tracking rate expanded to 135 bpm.

Furthermore, the delivery system was upgraded with a rounded catheter tip, reducing pressure on the heart wall by up to 66%. Simulation-based analysis also suggested a potential reduction in perforation risk.

Song stated, "As the heart-mechanical signaling monitoring function is improved, the device can now stably relay signals in a wider range of heart rates," adding, "Previously, device selection depended on patient conditions. Now, the latest improvement widened the range that a sing device can cover."

Impact of expanded reimbursement…changes brought by clinical introduction

Clinical experts have also offered positive evaluations regarding the expanding role of leadless pacemakers.

Professor Hee Tae Yu

Professor Hee Tae Yu of Cardiology at Severance Cardiovascular Hospital stated, "Leadless pacemakers have opened up treatment possibilities for patients for whom conventional transvenous pacemakers were difficult. They are effectively an essential option for patients at high risk of infection or those with difficult venous access."

Yu added, "The extended battery life and improved algorithms increase the consistency and predictability of treatment outcomes," and explained, "It is meaningful for long-term strategies."

The domestic launch of Micra AV2 is particularly noteworthy as it coincides with the reform of the insurance coverage criteria for leadless pacemakers.

As of December 1 last year, the Ministry of Health and Welfare limited the patient co-payment rate to 5% for cases where transvenous electrode insertion is impossible or has failed (e.g., venous stenosis, occlusion, or congenital malformations) and for patients with a current or past history of Cardiac Implantable Electronic Device (CIED) infection.

Professor Yu noted, "With reimbursement currently applied to high-risk groups, the range of choices for leadless pacemakers in clinical settings has clearly widened. As more clinical data accumulates, there is a possibility that the target population will gradually expand."

Future scope of application…coexistence with transvenous systems

Despite the system's expansion, reimbursement limitations remain a key issue. During the Q&A session, the scope of application emerged as a more central topic than the technology itself.

Photos of Medtronic's implantable cardiac devices

Professor Yu stated, "From a purely medical judgment perspective, it would be ideal to have no reimbursement restrictions. There are cases where a leadless pacemaker is more suitable, yet criteria limit the choice."

In particular, Yu noted that elderly patients could be important candidates and emphasized the need for ongoing discussions on expanding coverage as clinical experience grows. However, the current application of essential coverage for high-risk groups was evaluated as a meaningful institutional starting point.

Regarding traditional pacemakers, a period of coexistence is expected for leadless pacemakers and 

"At this stage, leadless pacemakers are not the primary choice for all patients," Professor Yu explained. "The role of transvenous pacemakers still exists." 

The transvenous method allows adjustment of electrode positions to maintain a more physiological conduction path, remaining a crucial option for younger patients or those who will be dependent on a pacemaker for a long time.

In conclusion, Yu noted, "While leadless pacemakers are advancing rapidly, the current structure where they share purposes and coexist with transvenous pacemakers will be maintained for now. However, if leadless technology capable of physiological pacing is secured in the future, the scope of application could expand even further."