The existing electrophysiology market is very considerable, and the incremental market has unlimited potential. Research institution BTIG predicts that half of atrial fibrillation ablations may be replaced by PFA in the next three years. In the new business of PFA, electrophysiology giants dare not be tired at all.

Recently, Boston Scientific announced that it has obtained approval from Japanese regulators for the FARAPULSE™ pulsed field ablation system.

Nick Spadea-Anello, president of Boston Scientific Electrophysiology, said that the FARAPULSE PFA system is the most clinically studied PFA system. To date, it has been used to treat more than 125,000 patients worldwide and continues to strengthen its strong safety, effectiveness and efficiency characteristics. "The rapid adoption of the FARAPULSE PFA system, which is now approved in more than 65 countries, demonstrates a paradigm shift in the treatment of paroxysmal atrial fibrillation - an approach that has clinical benefits for both physicians and patients - and we look forward to bringing this differentiated technology to Japan."

Prior to this, in July this year, Boston Scientific's FARAPULSE™ series of pulsed electric field ablation products were approved by NMPA, making it the world's first PFA system approved for marketing by the EU CE, the US Food and Drug Administration (FDA), and the China National Medical Products Administration (NMPA). Unlike traditional thermal ablation, which uses extreme heat or cold to ablate cardiac tissue associated with atrial fibrillation, the FARAPULSE PFA system uses a non-thermal electric field to avoid damage to surrounding structures.

In addition to the solid clinical evidence of the FARAPULSE PFA system, Boston Scientific expects to initiate the OPTION-A clinical trial in Japan, China, Taiwan and Hong Kong in early 2025 to study the safety and effectiveness of concurrent procedures using the FARAPULSE PFA system for cardiac ablation and the WATCHMAN FLX™ Pro left atrial appendage closure device.

Medtronic, which is also in the PFA war, has also made continuous progress. On September 27, Medtronic announced the results of a clinical study on the PulseSelect™ pulsed field ablation (PFA) system for the treatment of atrial fibrillation (Afib), showing that the system has a high rate of durable lesion formation. Invasive reconstruction performed approximately two months after the operation showed that the PulseSelect PFA system achieved durable isolation in 98% of pulmonary veins (PV) and 96% of patients. Similarly, Medtronic's PFA product was recently approved in China. In September, the National Medical Products Administration approved the launch of Medtronic's PulseSelect system, which consists of two innovative products: "heart pulse electric field ablation device" and "disposable heart pulse electric field ablation catheter". This is the first PFA product approved by NMPA that can be used for both paroxysmal and persistent atrial fibrillation. This is also the second foreign giant to enter the Chinese PFA market after Boco. Similarly, Medtronic's product was also approved in Japan in May this year.

Johnson & Johnson is a little slower than Boco and Medtronic in the field of PFA, but has continued to achieve results. Johnson & Johnson's PFA catheter VARIPULSE has been approved in Japan and Europe, and has applied for registration in the United States. Johnson & Johnson expects to enter the US PFA market at the end of this year or next year. The RF/PFA dual-energy ablation catheter has been submitted for CE certification. The new PFA product Omnypulse recently completed the enrollment of the clinical study (Omny-IRE). Abbott's new Volt™ Pulsed Field Ablation (PFA) system has also been officially applied to humans, and the clinical study required for Volt PFA CE registration was completed in March.

According to Frost & Sullivan data, the global cardiac electrophysiology device market size reached US$7.013 billion in 2021, and is expected to reach US$14.491 billion and US$32.450 billion in 2025 and 2032, respectively. In 2021, the Chinese cardiac electrophysiology device market size reached 6.58 billion yuan, and is expected to increase to 15.726 billion yuan in 2025 and 41.973 billion yuan in 2032.

The huge market potential has attracted giants to covet. From Johnson & Johnson's $16.6 billion acquisition of Abiomed to Mindray's acquisition of Huitai Medical, electrophysiology acquisitions have been ongoing. Before Poco and Medtronic, two companies' PFA products had been approved in the Chinese market, namely Jinjiang Electronics and Deno Electrophysiology.

On December 27 last year, Jinjiang Electronics' LEAD-PFA cardiac pulse electric field ablation device and PulsedFA disposable cardiac pulse electric field ablation catheter were approved for listing by NMPA, becoming the first PFA product approved for listing in China. It took less than 1 year from the completion of clinical trials to approval. According to the company's prospectus, the Pulsed FA disposable cardiac pressure pulse electric field radiofrequency ablation catheter is expected to be approved in the fourth quarter of 2024, which will further improve the company's product layout in the PFA field.

In addition, Beixin Medical's PFA products have also entered the NMPA review process, in addition to Xuanyu Medical, Aikemai Medical, Xinlutong, Zhouling Medical, Yuanshan Medical, etc. The PFA products of many other domestic companies have also entered various clinical stages, including Huitai Medical, Micro Electrophysiology, Maiwei Medical, etc.

It has been observed that since PFA was first used for human atrial fibrillation ablation in 2018, the world's enthusiasm for PFA research has been high, and the subsequent approval of foreign giants has also confirmed the broad market prospects of this field in the future. Although domestic enterprises started to deploy PFA later than foreign enterprises, the overall gap is not big because it belongs to an emerging field, and they are already in a leading position in the speed of product approval.

With the approval of domestic and foreign products, PFA products are about to be commercialized. 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, and 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 equipment is also expected to continue to rise, from 8.18% in 2025 to 38.87% in 2032. It can be foreseen that many PFA products will enter the sprint stage of listing one after another, and the domestic market will also usher in a new round of electrophysiological giants.

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