Recently, Abbott announced its latest progress in electrophysiology pulsed field ablation (PFA). Specifically, the global IDE registration of the Volt™ PFA system was completed ahead of schedule; the tactical flex™ Duo ablation catheter Sensor Enabled™ is undergoing the global FOCALFLEX trial; the Advisor™ HD Grid X mapping catheter Sensor Enabled™ has been approved by the US Food and Drug Administration and has begun commercial release.

According to Abbott's official website, the above two catheters are being developed as important tools for doctors to treat patients with abnormal heart rhythms such as atrial fibrillation (AFib). Among them, the mapping catheter will further support the mapping of PFA and radiofrequency ablation cases, and the visualization of cardiac anatomy is crucial for patients undergoing ablation surgery to achieve the best results. It is reported that the enrollment of the US VOLT-AF IDE study was completed 4 months ahead of schedule, and nearly 400 patients were enrolled in just 3 months. In addition, the FOCALFLEX pulsed field ablation study is also currently underway and is expected to be launched soon in the United States, with approximately 200 patients at 25 locations.

The rapid development of PFA has opened up a new battlefield for electrophysiology. Research organization BTIG predicts that half of atrial fibrillation ablations may be replaced with PFA in the next three years. The battle between giants around this emerging market has become fierce. In July this year, Boston Scientific's FARAPULSE™ PFA system was approved by NMPA for innovative products, becoming the first PFA product approved by FDA, CE and NMPA at the same time. According to the 2024Q2 financial report of Boston Scientific, thanks to the Farapulse system, its electrophysiology business sales increased by 125% over the same period.

Medtronic's PulesSelec has also been approved by CE\FDA\Japanese regulation\NMPA. The latest clinical research results show that the system has a high rate of persistent lesion formation. Invasive reconstruction performed about two months after surgery showed that the PulseSelect PFA system achieved persistent isolation in 98% of pulmonary veins (PV) and 96% of patients.

Johnson & Johnson's PFA product Omnypulse recently completed clinical research enrollment. Previously, its Varipulse pulse ablation PFA was approved for marketing by CE, becoming the third company to obtain CE approval for PFA products after Medtronic and Boston Scientific. The influx of giants has brought uncertainty to the existing PFA market. The track full of strong players has put forward higher requirements for product innovation and effectiveness, and the pressure on domestic brands that started later has increased sharply.

According to Frost & Sullivan's forecast, the scale of China's PFA market will reach 1.3 billion yuan in 2025 and maintain rapid growth. It is expected to reach 16.3 billion yuan in 2032, with a CAGR of 43.73% during the period. The proportion of China's PFA market scale in the overall market scale of electrophysiological devices is also expected to continue to rise, from 8.18% in 2025 to 38.87% in 2032. Among the above giants, Boston Scientific and Medtronic have officially entered the domestic market, and have exerted strong competitive pressure on domestic players with their technological advantages and brand value. So far, two domestic companies have approved their PFA products for marketing, namely Jinjiang Electronics and Denuo Electrophysiology. In addition, Huitai Medical, Micro Electrophysiology, Maiwei Medical and many others have also entered the clinical enrollment stage.

Although competitors are strong, local brands also have objective advantages in the domestic market, including faster approval speed. For example, in December 2023, Jinjiang Electronics' LEAD-PFA cardiac pulsed electric field ablation instrument and PulsedFA disposable cardiac pulsed electric field ablation catheter were approved for marketing by NMPA. It took less than one year from the completion of clinical trials to approval. Guolian Securities Research Report mentioned that as more manufacturers complete clinical trials, many domestic brands enter the special review process, and are expected to overtake in the PFA field and break the monopoly of imported companies in the field of three-dimensional electrophysiological ablation for many years.

In addition, with the gradual implementation of the electrophysiological centralized procurement policy, the utilization rate of domestic mapping and ablation catheters has increased. Domestic companies with faster PFA layout are expected to take the lead in the next round of centralized procurement and give priority to expanding more hospital channels. According to the Frost & Sullivan report, the number of cardiac electrophysiology surgeries in China will reach 210,000 in 2021, with a CAGR of 11.60% from 2017 to 2021. With the aging of the population, the increasing number of patients, and the increasingly convenient medical conditions, the number of surgeries has continued to grow, and it is expected to reach 570,000 in 2025, with a CAGR of 28.00%. From the perspective of existing domestic medical resources, the application of PFA in China still requires a relatively long time, and the intermediate conversion period can provide a certain growth time for domestic PFA, which can be used to check for gaps when using products in the industry such as Poco and Medtronic, and find new clinical pain points to enhance competitiveness.

According to the research data of The Lancet sub-journal in 2022, the current national atrial fibrillation population is estimated to have reached 20 million, and it is estimated that by 2050, about 9 million elderly people over 60 years old in China will suffer from atrial fibrillation. Given such a huge potential market, it is unlikely that a winner-takes-all situation will emerge in the domestic PFA track. At this stage, domestic brands that focus on honing their technology and cost-effectiveness still have room to break through, and the final market winner remains a mystery.

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