Domestic Electrophysiology Market Heats Up as PFA Innovation Sparks Fierce Competition

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Medtronic PFA Approved

Electrophysiology Market Launches Ace Battle

Following Boston Scientific, Medtronic has officially entered the Chinese PFA market. The two multinational medical device giants are about to launch a new round of competition in China's electrophysiology market.

On September 10, the National Medical Products Administration (NMPA) disclosed,Medtronic's "Cardiac Pulsed Field Ablation System" and "Single-Use Cardiac Pulsed Field Ablation Catheter" have been approved for registration as innovative products.

According to the National Medical Products Administration, the above two products are used in conjunction, utilizing the non-thermal effect principle of pulsed electric fields to treat drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug-refractory, recurrent, symptomatic persistent atrial fibrillation (with episodes lasting less than one year). Compared with traditional radiofrequency ablation and cryoablation products, these products can achieve selective destruction of myocardial tissue, avoiding the risk of damage to surrounding tissues caused by temperature transfer.

Atrial fibrillation is a common age-related disease. Data shows that the risk of stroke in patients with atrial fibrillation is 7 times higher than that of the general population, reaching up to 35%. According to research data from a 2022 study published in a subsidiary journal of The Lancet, it is estimated that there are currently 20 million people with atrial fibrillation in China, and it is projected that by 2050, approximately 9 million people over the age of 60 in China will suffer from atrial fibrillation.

In the treatment of atrial fibrillation, PFA is considered a revolutionary technology with broad prospects.

In July this year, Boston Scientific's PFA product received NMPA innovative product approval, becoming the first PFA product to simultaneously obtain approvals from the FDA, CE, and NMPA. Prior to this, two companies' PFA products had already been approved in the Chinese market: Jinjiang Electronic and Nuomao.

Products from four companies have all been approved for innovative medical device registration applications.In comparison,The PFA products of Jinjiang Electronic, Nuomao, and Boston Scientific are mainly used for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation. Medtronic's PFA products can also be used to treat drug-refractory, recurrent, symptomatic persistent atrial fibrillation (with an episode duration of less than 1 year).

It has been less than a year since the first PFA product in China was approved, and already four companies, including two multinational giants, have entered the Chinese PFA market stage. According to observations,Currently, PFA-related academic activities are proceeding in China, with multiple medical institutions successfully conducting PFA surgeries.

According to incomplete statistics,In addition to the approved companies, many domestic companies are currently advancing the clinical trials and registration approval of PFA products.

Among them, the VARIPULSE catheter from Johnson & Johnson entered the NMPA Innovative Medical Device Special Review Process in February 2021. In China, a number of companies such as HT Medical, MicroPort EP, Ever Mountains Medical, ZHOU MedTech, RuiDao Medical, HanYu Medical, MaiWei Medical, XuanYu Medical, Aikangmai Medical, Shangyang Medical, and Ruidi Biotech have also entered the PFA field.

According to the disclosed information of listed companies, HuTai Medical's circular pulsed ablation catheter and magnetoelectric positioning pressure-sensing pulsed ablation catheter have entered the registration review stage. The pressure pulse ablation catheter of MicroElectroPhysiology is currently in the clinical trial stage and is expected to obtain NMPA registration in 2025. The pulsed electric field ablation project of Shanghai Shangyang Medical Technology Co., Ltd., a subsidiary of MicroElectroPhysiology, has been submitted for registration in China and is expected to obtain NMPA registration in the first half of 2025.

It can be seen that Chinese electrophysiology manufacturers are no less sensitive and competitive in cutting-edge innovation. However, competing directly with the two multinational giants remains a significant challenge.

In addition, China's medical device market is undergoing industry changes brought about by policies such as volume-based procurement. A large number of products in the electrophysiology market have already fallen within the price reduction range. Positioned in the cutting-edge innovative field, PFA products may not be immediately affected by pricing issues, but there remains uncertainty in the long term.

Electrophysiology Market Shows High Growth

PFA May Become a Turning Point in the Industry

The electrophysiology sector is one of the fastest-growing segments in the current medical device market. Johnson & Johnson Medical Technologies, which holds a leading position in this market, can generate over a billion dollars in revenue in a single quarter.

According to Frost & Sullivan data, the global market size for cardiac electrophysiology devices reached USD 7.013 billion in 2021 and is expected to reach USD 14.491 billion by 2025 and USD 32.450 billion by 2032.

In 2021, the market size of China's cardiac electrophysiology devices reached 6.58 billion yuan, and it is expected to increase to 15.726 billion yuan by 2025, reaching 41.973 billion yuan by 2032.

Within the electrophysiology market, the innovation competition in the PFA field could become a turning point for the industry. Research firm BTIG predicts,Within the next three years, half of the atrial fibrillation ablation procedures may switch to PFA.

In this clash of the titans, Medtronic struck first with good news in the U.S. market, becoming the first company to secure FDA approval. Not far behind, Boston Scientific also announced its FDA approval just over a month later.

Johnson & Johnson's progress in the PFA field is slower than that of Medtronic and Boston Scientific. However, Johnson & Johnson's PFA catheter VARIPULSE has been approved in Japan and Europe, and it is already in the United States.Johnson & Johnson is expected to enter the U.S. PFA market by the end of this year or next year for registration. The dual-energy RF/PFA ablation catheter has been submitted for CE certification. The new PFA product, Omnypulse, has recently completed patient enrollment for its clinical study (Omny-IRE).

As PFA products continue to gain approval in major markets worldwide, the outcome of this "battle of the titans" is about to be revealed.

Author: Dongtai

WeChat ID: sssqy1218

Editor: Qin Jiu

WeChat ID: nrzx0321