3D Cardiac Electrophysiology Surgeries Emerge as the Standard: Antech Medical's Balloon Cryoablation Catheter Receives Market Approval

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Recently, the National Medical Products Administration approved the innovative product registration application for Artechmed's "Balloon-Type Cryoablation Catheter." Last month, the National Medical Products Administration had already approved the company’s innovative product registration application for the "Cryoablation System."

It is reported that Artechmed's balloon-type cryoablation catheter, consisting of a balloon-type cryoablation catheter and a manual retractor, is used in conjunction with a specific cryoablation instrument to treat adult patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

The "32mm large balloon" and "8mm short tip" design used in this product can stably control the flow of refrigerant, effectively manage freezing temperature, and closely approach the pulmonary vein ostium to efficiently capture pulmonary vein potentials, thereby ensuring effective cryoablation. Compared to similar domestic and foreign products available in China, this technology is a pioneering innovation. The launch of this product can further meet China's clinical needs in the field of paroxysmal atrial fibrillation treatment.

It is reported that cryoablation refers to an interventional technology where a balloon catheter is delivered to a specific area of the heart through puncture. A liquid refrigerant is injected into the balloon catheter, and by means of the refrigerant's evaporation and heat absorption, tissue heat is removed, lowering the temperature at the target ablation site. This interrupts the electrical signal conduction in specific areas, thereby reducing the risk of arrhythmia.

As early as August 2023, Artechmed's cryoablation product series had already been launched, breaking the ice in China’s domestically produced cryoablation atrial fibrillation market. In August 2023, Artechmed's IceMagic@ Balloon Cryoablation Catheter and IceMagic@ Cryoablation System received NMPA registration approval, becoming the first domestically produced cryoablation product approved for atrial fibrillation treatment in China. To date, it has been listed in more than 20 provinces and has been piloted at several centers, including the General Hospital of the People's Liberation Army Northern Theater Command and Wuhan Asia Heart Hospital. The product has shown excellent performance in temperature control technology, contact, and occlusion, further enhancing surgical safety and efficiency.

In terms of 3D cardiac electrophysiology procedures, Artechmed's IceMagic@ balloon-type cryoablation catheter will be used in conjunction with the IceMagic@ cryoablation system. The cryoablation catheter, working together with the cryoablation system, delivers ablative energy to the tissue, causing a sudden drop in temperature around the ablation target. This results in damage or death to the abnormal myocardial cells in that area, and is used for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

Overall, the volume of cardiac electrophysiology procedures is growing rapidly. In the future, the accelerating trend of population aging in China will lead to a rise in the incidence of cardiovascular diseases, which will drive the overall increase in market demand for the cardiovascular industry. As the advantages of cardiac electrophysiology procedures are gradually clinically validated, the number of such procedures for treating tachyarrhythmia patients in China continues to grow.

According to statistics and forecasts by Frost & Sullivan, the number of electrophysiology procedures in China increased from 138,000 cases in 2017 to 214,000 cases in 2021. With the improvement in disease awareness and the reduction in procedure costs due to centralized procurement, it is expected to reach 575,000 cases by 2025, with a compound annual growth rate (CAGR) of 28% from 2020 to 2025E.

At the same time, the penetration rate of complex arrhythmia surgeries such as atrial fibrillation is gradually increasing. Among tachyarrhythmias, the pathogenesis of atrial fibrillation is relatively complex, and the ablation surgery is more difficult. Therefore, in the treatment of atrial fibrillation, a three-dimensional mapping system is usually required for more precise cardiac modeling to facilitate accurate treatment by doctors.

Driven by a series of factors such as the development of 3D mapping technology and the promotion of atrial fibrillation centers, the number of electrophysiological atrial fibrillation surgeries is expected to increase from 101,000 cases in 2021 to 383,000 cases in 2025, with an annual compound growth rate as high as 39.56%. The annual compound growth rate from 2025 to 2032E will still be 19.4%, much higher than that for supraventricular tachycardia and other conditions.

Obviously, three-dimensional cardiac electrophysiology procedures have become the mainstream approach. With advancements in three-dimensional mapping equipment and consumables technology, along with their expanded clinical application, three-dimensional cardiac electrophysiology procedures have gradually surpassed two-dimensional procedures to become the predominant method in cardiac electrophysiology treatments.

Currently, radiofrequency ablation is a commonly used ablation technology in cardiac electrophysiology clinics. Cryoablation, as an innovative technology in the field of atrial fibrillation treatment, offers clinical advantages such as shorter operation time, ease of use, and a short learning curve, providing new options for cardiac electrophysiologists and atrial fibrillation patients. In addition, other technologies like pulsed electric field ablation will offer more clinical approaches to patients in the future.

The favorable policies, on the other hand, have accelerated the process of domestic substitution, with significant room for import replacement. In recent years, China has introduced policies such as the "14th Five-Year Plan for the Development of Medical Equipment Industry," the "Outline of the National Health Care Service System Plan," and the "Implementation Opinions on Comprehensively Promoting the Comprehensive Reform of County-Level Public Hospitals." These policies explicitly encourage the development of innovative medical devices and require a gradual increase in the configuration level of domestically produced medical equipment, strongly promoting the development and strategic layout of domestic companies in the field of electrophysiological surgical instruments. In addition to the top-level design policy support for domestic medical devices from the State Council, local governments in Fujian, Sichuan, Hubei, and other regions have also clearly stated during the implementation of bidding and procurement that domestically produced medical devices can be preferentially procured, thereby speeding up the market entry and sales pace of domestically produced medical devices.

It can be foreseen that, in the future, with the orderly advancement of various favorable policies for domestic substitution, the market size growth rate of domestically produced electrophysiological medical devices is expected to rise rapidly.

In short, cardiac electrophysiology interventional technology can help doctors understand the electrophysiological characteristics of the cardiac conduction system, clarify the mechanism of arrhythmia, and thus choose an appropriate clinical treatment plan. Benefiting from advancements in positioning and navigation technology as well as the maturity of minimally invasive techniques, the detection rate of heart diseases has significantly increased. Cardiac electrophysiology interventional technology has rapidly developed in the diagnosis and treatment of arrhythmias, becoming one of the hotspots in the field of cardiac electrophysiology.

Taking Artechmed as an example, on May 10, 2023, the Beijing Medical Institution DRG Joint Procurement Group issued the "Notice on Soliciting Opinions for the First DRG Payment and Volume-based Procurement Policy Joint Procurement Plan in Our City". Multiple products from Artechmed, including the IrueForce Pressure Catheter and EasyStars Star Mapping Catheter, were awarded across the board.

On August 24, 2023, the Tianjin Medical Procurement Center released the "Notice on the Implementation of the Electrophysiology-related Medical Consumables Volume-based Joint Procurement for the Beijing-Tianjin-Hebei '3+N' Alliance." All four sets and individual components of MicroPort EP's core products, including the cryoablation series, were successfully awarded contracts. The concentrated procurement of electrophysiology products in China is being carried out intensively, significantly shortening the hospital approval process for domestically produced electrophysiology products, accelerating the promotion of domestic manufacturers' products in hospitals, and continuously speeding up the substitution process of domestically produced products.

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