Pulsed field ablation gains reimbursement in Korea

Reimbursement listing for PFA procedures expands patient access

Boston Scientific’s early approval advantage faces pursuit from J&J and Medtronic

Market shifting from product competition to platform competition

Reference Material (AI-generated image)

The atrial fibrillation ablation market has entered a full-scale competition following reimbursement coverage for pulsed field ablation (PFA).

PFA has been garnering attention as a next-generation technology capable of replacing existing radiofrequency and cryoablation procedures, but its adoption was limited due to non-reimbursement barriers. However, with national health insurance coverage beginning in May, patient access has improved, and market conditions are changing.

In particular, because the reimbursement applies not to a specific company’s product but to the ‘PFA procedure’ itself, Boston Scientific, Johnson & Johnson (J&J), and Medtronic are all expected to compete under the same regulatory framework.

Reimbursement marks a turning point in the market... Will PFA adoption accelerate?

PFA is an ablation procedure that uses high-voltage electric fields to selectively damage myocardial cells. Unlike conventional radiofrequency ablation or cryoablation, which rely on heat, PFA is considered a next-generation atrial fibrillation treatment because it can reduce damage to surrounding tissues.

In particular, its ability to reduce the risk of complications, such as esophageal injury, phrenic nerve injury, and pulmonary vein stenosis, which were concerns with traditional thermal ablation, is cited as a key strength. Combined with the potential for shorter procedure times, the shift to PFA is already progressing rapidly in the global market.

According to a report by the Korea Health Industry Development Institute, Korea’s PFA market is expected to grow from approximately USD 31 million in 2024 to around USD 53 million by 2029, representing a compound annual growth rate of 11.1%.

The global PFA market is projected to expand from approximately USD 1.53 billion in 2024 to about USD 9.25 billion by 2029.

In practice, even during the non-reimbursed stage, some major tertiary hospitals had already accumulated experience using PFA. According to the report, Severance Hospital introduced PFA at the end of 2024 and has been actively using it since 2025.

Out of roughly 1,000 total atrial fibrillation ablation procedures currently performed, about 350 are now conducted using PFA, and the hospital expects more than 70% of all procedures to eventually transition to PFA.

Ultimately, while PFA was previously used only on a limited basis depending on whether patients had out-of-pocket insurance coverage, its reimbursement coverage is expected to reduce cost barriers and position PFA as a major treatment option for atrial fibrillation ablation.

Market Size and Growth of Korea's PFA Market (Reconstructed AI image of Korea Health Industry Development Institute's report)

Boston Scientific’s early approval advantage…J&J focuses on integration, Medtronic on expandability

According to the medical device industry, Boston Scientific currently holds the leading position in the early competitive landscape.

Boston Scientific’s Farapulse PFA platform became the first medical device approved in Korea for PFA when it received Ministry of Food and Drug Safety approval in September 2024.

Boston Scientific emphasizes that, in connection with the new reimbursement coverage, it possesses both the “Farawave PFA Catheter,” capable of two-dimensional visualization, and the “Farawave NAV PFA Catheter,” which enables three-dimensional visualization of treatment sites.

Farapulse’s strengths lie in its early approval and accumulated clinical evidence. According to the company, Farapulse has built up safety and efficacy data through studies such as the ADVENT trial, which directly compared it with thermal ablation, and the MANIFEST-17K registry, which analyzed real-world clinical outcomes in more than 17,000 patients.

Its competitor, Johnson & Johnson, is promoting a different type of competitiveness through Varipulse. The Varipulse system is a three-dimensional PFA treatment solution consisting of the Varipulse catheter, TruPulse generator, Carto3 3D mapping system, and Vizigo Steerable Sheath.

Its key advantage is integration. Varipulse is designed to integrate with J&J’s electroanatomical mapping system, Carto 3. Because confirming catheter position, visualizing cardiac structures, and identifying lesion locations are increasingly important during PFA procedures, integration with mapping systems may become an important factor in hospital purchasing decisions.

Being somewhat of a late entrant in Korea, Medtronic is establishing a competitive presence in terms of expandability.

Medtronic’s PulseSelect PFA system received U.S. FDA approval in December 2023 for the treatment of paroxysmal and persistent atrial fibrillation. The company is expected to leverage the fact that PulseSelect was the first PFA system approved by the FDA, along with its global clinical usage experience.

Another differentiating point for Medtronic is its future product lineup. Through products such as the dual-energy Affera Mapping and Ablation System, which combines pulsed field and radiofrequency energy, and the Sphere-9 Catheter, the company is pursuing a strategy of expanding treatment areas beyond atrial fibrillation into atrial flutter and ventricular tachycardia.

KHIDI Report (AI image reconstruction)

Competition lies in hospital workflows rather than products

Following reimbursement listing for PFA, market competition is likely to unfold not as a one-sided dominance by a specific company, but rather as a diversification of selection criteria among individual hospitals.

Atrial fibrillation ablation procedures are not determined by a catheter alone. Mapping systems, imaging equipment, physician expertise, existing hospital equipment infrastructure, training support, long-term clinical data, and cost structures all play important roles. As a result, preferred platforms may vary from hospital to hospital.

For example, hospitals prioritizing early adoption experience and accumulated clinical evidence may favor Boston Scientific’s Farapulse, while hospitals already operating electrophysiology workflows centered on the Carto3 system may choose J&J’s integrated Varipulse solution.

Hospitals focusing on future technologies and expandability of indications may instead see Medtronic’s long-term product lineup as more competitive.

Nevertheless, the general consensus is that as PFA becomes mainstream, the atrial fibrillation ablation market has entered a full-fledged transition phase.

Whereas the technology was previously used mainly by select patients and leading hospitals, patient accessibility and hospital adoption potential are now expanding simultaneously.

As a result, while domestic approval and early adoption were previously the key competitive factors, post-reimbursement competition is expected to depend increasingly on real-world experience, interoperability with existing hospital equipment, procedural training, data accumulation, and the speed of follow-up product introductions.

A medical device industry official said, “In overseas markets such as the United States, PFA is already rapidly establishing itself as the standard of care. With reimbursement now improving patient access in Korea as well, the transition toward PFA driven by procedural efficiency and safety is expected to accelerate further.”