Adoption of pulsed field ablation gains momentum in Korea

Domestic market projected to reach KRW 72 billion by 2029

Global Big 3 pharmas compete to secure early market leadership

Reimbursement and clinical data accumulation to determine the pace of adoption

PFA at Asan Medical Center

The treatment paradigm for atrial fibrillation (AF) is rapidly shifting from conventional thermal ablation techniques to the non-thermal approach of pulsed field ablation (PFA).

Global medical device companies are sequentially entering the Korean market, signaling the beginning of an intense competition for market share.

According to a report released by the Korea Health Industry Development Institute (KHIDI) on the 29th, the global PFA market size is projected to grow from approximately USD 1.5 billion (KRW 2.15 trillion) in 2024 to USD 9.2 billion (KRW 13.20 trillion) by 2029, representing a compound annual growth rate (CAGR) of around 41.1%.

PFA emerges as the game changer... strengths in safety and procedure efficiency

PFA utilizes the principle of ‘irreversible electroporation (IRE)’, which uses a high-voltage electric field to create microscopic pores in cell membranes.

Unlike radiofrequency ablation (RFA) or cryoballoon ablation (CBA), which rely on thermal energy and carry risks such as esophageal injury and phrenic nerve palsy, PFA is evaluated as reducing major complications associated with conventional ablation, such as esophageal injury, phrenic nerve damage, and pulmonary vein stenosis.

Clinical data also support this. Results from the ADVENT clinical trial involving 607 patients demonstrated PFA's 12-month treatment success rate of 73.3%, demonstrating non-inferiority compared with conventional thermal ablation techniques (71.3%).

Notably, the incidence of pulmonary vein stenosis was just 0.9% in the PFA group, compared with 12% in the conventional ablation group, and no cases of esophageal damage were reported.

Building on these strengths, market penetration in Korea is expected to accelerate. The domestic PFA market is projected to grow at an average annual rate of 11.1%, expanding from approximately USD 31 million (KRW 42 billion) in 2024 to USD 53 million (KRW 72 billion) by 2029.

Market size and growth rate of PFA in Korea

Global “Big 3” secure Korean approvals… adoption accelerates at tertiary hospitals

The Korean PFA market is currently shaping up as a three-way competition among Boston Scientific, Medtronic, and Johnson & Johnson (J&J).

Boston Scientific took the lead with its FARAPULSE platform, obtaining catheter approval in April 2024 and generator approval in September.

Following Korea’s first successful PFA procedure at Severance Hospital in December last year, the number of adopting hospitals is rapidly increasing.

J&J’s VARIPULSE system received catheter approval in August 2024 and emphasizes its fully integrated workflow with its proprietary 3D mapping system, CARTO 3, as a key competitive advantage.

Medtronic's ‘PulseSelect’ followed suit, entering the fray in January 2025 with Class III medical device approval for its integrated catheter and generator system.

The company has further strengthened its lineup with the Sphere-9 catheter, capable of high-density mapping and dual RF/PF ablation.

Major global medical device companies' PFA approval status

“Clear clinical value”…but reimbursement remains the key to wider adoption

Clinicians have expressed positive views on PFA adoption.

Professor Boyoung Joung of the Cardiology Department at Severance Hospital stated, “PFA cuts procedure time by nearly half compared to conventional methods while significantly reducing complication risks, leading to high satisfaction among both physicians and patients. Currently, about 35% of atrial fibrillation ablation procedures at Severance Hospital are performed using PFA, and this proportion is expected to continue rising.”

According to an analysis of real-world data (RWD)-based cost outcomes collected from hospitals in Belgium, Germany, and the Netherlands, the direct costs per patient during the initial procedure (including personnel, time, anesthesia, tests, hospitalization, etc.) were 22% lower than CBS and 35% lower than RFA.

From the patient perspective, while immediate cost savings were modest, cumulative reductions were observed over time due to fewer repeat procedures and lower complication management costs.

However, regulatory hurdles remain. Although PFA passed the New Health Technology Assessment in December last year, it has yet to be listed for reimbursement, pending inclusion in the National Health Insurance reimbursement list. Currently, whether a patient has indemnity health insurance significantly influences their choice.

An industry insider commented, “In markets such as the U.S., PFA already accounts for over 70% of all ablation procedures and has effectively become the standard of care. Given its proven efficiency and safety, reimbursement and other institutional support in Korea would significantly accelerate the pace of market transition.”