China's First PFA System Approved: Jinjiang Electronics Accelerates Domestic Substitution in the Billion-Dollar Cardiac Electrophysiology Market

Jan 01, 2024 18:38 CST Updated 18:38

Jinjiang Electronic

Developer of electrophysiology products

Recently, the National Medical Products Administration approved the innovative product registration applications for "Disposable Cardiac Pulse Field Ablation Catheter" and "Cardiac Pulse Field Ablation Instrument" submitted by Sichuan Jinjiang Electronic Science and Technology Co., Ltd.

The disposable cardiac pulse electric field ablation catheter consists of a catheter and a connecting cable. The cardiac pulse electric field ablation instrument consists of a main unit, an output box, and accessories.Achieved a breakthrough from zero in China, as the first domestically produced cardiac pulsed field ablation product.

The above two products are used together to treat atrial fibrillation by controlling and releasing pulsed electric field energy of appropriate intensity, selectively causing irreversible electroporation damage to myocardial cells in the lesion areas that require treatment. This provides more options for treating drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

The First in China! Complete Electrophysiology Product Line

Currently, the IPO of Jinjiang Electronic is in progress. According to the prospectus,Jinjiang Electronic is one of the few companies in China with a complete line of cardiac electrophysiology products.Able to provide a comprehensive portfolio of equipment and consumables required for the entire process of cardiac electrophysiology procedures, including "mapping, modeling, ablation, and validation." Since its establishment, the company has gradually built a product lineup centered on a three-dimensional PFA (Pulsed Field Ablation) treatment solution through independent research and development. The company's core products include a magnetic and electrical positioning three-dimensional mapping system, a cardiac pulsed electric field ablation device, and accompanying catheters. In addition, the company’s product range covers other cardiac electrophysiology products such as multi-channel physiological recorders, radiofrequency ablation systems, radiofrequency ablation catheters, and access consumables. With a rich product hierarchy, the company is able to offer complete solutions for patients with tachyarrhythmia. Meanwhile, the company has extended its product line into the pain management field, meeting more diversified clinical needs.

Cardiac pulsed electric field ablation is a new type of ablation method that uses pulsed electric fields as energy.Pulsed Electric Field Ablation

This approval is for Jinjiang ElectronicLEAD-PFA® Cardiac Pulsed Field Ablation System and PulsedFA® Single-Use Cardiac Pulsed Field Ablation CatheterIn June 2022, it entered the special review process for innovative medical devices (Green Channel). The registration clinical trial of the LEAD-PFA cardiac pulse electric field ablation device was launched in July 2021, and it took only more than four months to complete the enrollment of all cases.Becoming the first PFA product to complete patient enrollment in a registration clinical trial in the Chinese market, and currently the first cardiac pulsed field ablation product to receive NMPA approval for marketing in China.

Jinjiang Electronic's LEAD-PFA cardiac pulse electric field ablation device is the world's first PFA product based on a full magnetic positioning 3D system. In addition to possessing all the advantages of PFA pulse electric field ablation technology, it can also seamlessly integrate with Jinjiang's own LEAD-Mapping full magnetic positioning 3D system, combining 3D modeling, mapping, and ablation functions in one. It enables green electrophysiological surgery (X-ray-free procedures, significantly reducing occupational risks for surgeons). Moreover, Jinjiang Electronic’s full magnetic positioning 3D PFA pulse ablation solution also offers significant advantages such as broad surgical indications, a short learning curve, and smooth surgical operation.

The cardiac electrophysiology market is vast, and the field is entering a phase of rapid development.

According to data from Frost & Sullivan, the number of patients with atrial fibrillation in China has exceeded 10 million. In the cardiac electrophysiology market, data from the National Health Commission's Arrhythmia Intervention Quality Control Center shows that: the number of ablation procedures for arrhythmia patients in China increased from 101,000 cases in 2014 to 152,000 cases in 2018, with a compound annual growth rate of 10.7%. It is expected that by 2023, the number of procedures will reach 336,000 cases, with a compound annual growth rate of 17.3%. With the increase in procedure volume, the market size of China's cardiac electrophysiology industry has grown from 1.13 billion yuan in 2014 to 3.33 billion yuan in 2018, with a compound annual growth rate of 30.9%.And it is expected that by 2023, the market size will reach 12.32 billion yuan.

Currently, the market potential for cardiac electrophysiology in China is enormous, with an electrophysiology procedure penetration rate of less than 1%, indicating significant room for growth; in the domestic cardiac electrophysiology market, the market share of domestically produced brands is less than 10%, presenting a vast space for domestic substitution.

Compared with traditional radiofrequency and cryo-energy, pulsed electric field ablation is a non-thermal energy ablation method. Therefore, the pulsed electric field can selectively damage myocardial tissue while preserving blood vessels, nerves, and surrounding tissues such as the lungs, esophagus, and phrenic nerve. Cardiac pulsed electric field ablation has the characteristics of not damaging the coronary arteries, not damaging the esophagus, not damaging nerves, and not damaging the extracellular matrix. Moreover, the ablation process is fast, with low contact requirements. Pulsed electric field ablation is not only rapid but also has minimal catheter-to-tissue contact requirements.In terms of gross observation, the scar continuity and homogeneity of pulsed electric field ablation are much better than those of radiofrequency ablation.

Relevant data shows that in 2022, radiofrequency ablation accounted for 88% and cryoablation accounted for 12% of atrial fibrillation ablation procedures in China. It is expected that pulsed field ablation will be commercialized in China within two years.It is estimated that by 2028, the number of atrial fibrillation ablation procedures in China will reach 590,000 cases, with pulse field ablation accounting for approximately 9%.

Pulsed Electric Field Ablation Shows High Growth Potential, Considered the Next Generation of Disruptive Ablation Technology. The Advent of Pulsed Ablation Brings Greater Room for Imagination to the Ablation Field, and a New Track Has Initially Taken Shape.

Global Market Landscape

Across the entire market, multinational medical device companies such as Boston Scientific, Johnson & Johnson, and Medtronic have already started to develop related product pipelines. Although China's pulsed field ablation (PFA) industry is still in the early stages of the market, multiple enterprises are actively making their moves. For instance, companies like Denovo EP, XuanYu Medical, Hithrone Medical, Aicopulse, Zonlin, Jinjiang Electronic, and HanYu Medical have placed bets on the emerging PFA technology that has only surfaced in recent years. Among them, besides Jinjiang Electronic receiving approval this time, Denovo EP’s related products also entered the special review process for innovative medical devices in the first half of 2022, positioning itself to potentially follow closely behind giants like Boston Scientific and Medtronic in achieving a late-market entry advantage.

Medtronic

Following the successful CE certification approval last month, Medtronic's electrophysiology product, the PulseSelect Pulsed Field Ablation (PFA) System, received further positive news on December 13. The PulseSelect has now been approved by the FDA. This product is used for treating paroxysmal and persistent atrial fibrillation and is the world’s first PFA device to receive FDA approval, marking a milestone achievement.

Boston Scientific

As a "rising star" in the PFA field, Boston Scientific's FARAPULSE PFA System received the FDA Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019, and obtained CE certification in January 2021, gaining approval in the European Union for the treatment of paroxysmal atrial fibrillation. In 2021, Boston Scientific’s FARAPULSE Pulsed Field Ablation System also entered the “green channel” for special review of innovative medical devices in China.

Denovo EP

CardioPulse™, a pulsed electric field ablation catheter developed by Denuo Electrophysiology, is the first of its kind in China. Its integrally molded ablation electrode can achieve pulmonary vein contact with various anatomical shapes, enabling rapid and safe ablation of the pulmonary veins while performing high-quality electrical signal mapping.

CardioPulse™ Pulsed Field Ablation Catheter completed the first atrial fibrillation pulsed field ablation surgery in Asia in December 2020. It is currently undergoing multi-center clinical trials and will apply for Class III registration approval from the National Medical Products Administration after completing the trials, with the hope of playing a significant role in the field of atrial fibrillation ablation as soon as possible. The catheter has passed the special review application for innovative medical devices and was approved to enter the special review process on May 25, 2022.

Huitai Medical

On February 15, 2023, it was announced that the pre-market clinical trial of HuTai Medical's innovative product, the cardiac pulse ablation PFA system, conducted at multiple centers in China, has successfully completed the enrollment of all patients. This cardiac pulse ablation PFA system is the world’s first ablation system that integrates three key features: "contact force sensing/tissue proximity indication," "magnetic and electrical dual-positioning 3D mapping," and "pulse ablation."

Xuanyu Medical

Xuanyu Medical's independently developed and produced "Multi-Channel Pulsed Electric Field Ablation Instrument" completed its first clinical trial in March 2022, showing significant efficacy. In June 2022, Xuanyu Medical announced the completion of a 100-million-yuan Series A round of financing.

Maiwei Medical

In August 2023, the world's first nanosecond pulsed electric field atrial fibrillation ablation (nsPFA) system, developed by Maiwei Medical, successfully completed all patient enrollments for its registration clinical trial. This system is currently the world’s only nsPFA product to have entered a registration clinical trial.

As the orderly progress of domestic substitution continues, the market share of domestically produced medical device manufacturers is expected to see a significant increase.

Source of the article: Medical Device Innovation Network

Reference: Jinjiang Electronic Official WeChat,SiYu Medical Devices

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