Recently, the National Medical Products Administration approved the registration application for the innovative product "Disposable Pressure Monitoring Radiofrequency Ablation Catheter" of Hunan Aptech Medical Equipment Co., Ltd. (hereinafter referred to as Aptech Medical).

Another flagship product has been approved
Established in 2006, Aptech Medical is a wholly-owned subsidiary of Shenzhen Huitai Medical Equipment Co., Ltd. (hereinafter referred to as Huitai Medical). Epert Medical is a high-tech enterprise specializing in the research, development, production, and sales of cardiac electrophysiology and interventional medical devices. Currently, it has formed a business layout with complete coronary access and cardiac electrophysiology medical devices as the main focus, and peripheral vascular and neural interventional medical devices as the key development direction.

It is understood that the disposable pressure monitoring radiofrequency ablation catheter from Epert Medical is composed of a head end, a tube body, a handle, a cable, a saline connector, and an optoelectronic hybrid plug. This product is used in conjunction with the cardiac radiofrequency ablation device from Shanghai Hongtong Industrial Co., Ltd. (hereinafter referred to as Hongtong Industrial) and is mainly used for the treatment of drug-resistant, recurrent, and symptomatic paroxysmal atrial fibrillation.

The disposable pressure monitoring radiofrequency ablation catheter can achieve real-time monitoring and feedback of pressure during clinical use through the built-in optical pressure sensor, ensuring the stability of ablation effect. This product can effectively reduce the risk of steam burst caused by tight contact between the catheter and tissue during surgery, or incomplete ablation caused by insufficient contact, benefiting more patients with paroxysmal atrial fibrillation.

It is worth mentioning that Hongtong Industrial is also a wholly-owned subsidiary of Huitai Medical. Its product, the cardiac radiofrequency ablation device, passed the NMPA's innovative product registration application on December 13, 2024.

It is reported that the product consists of a host, isolated power supply, foot switch, and accessory cables. The accessory cables include: 3D positioning device connection cable, serial computer interface cable, impedance monitoring connection cable, and grounding cable. This product is used in conjunction with disposable pulsed electric field ablation catheters and is mainly used for the treatment of atrial fibrillation.

The cardiac radiofrequency ablation device uses pulsed electric field ablation technology to selectively treat the tissue at the lesion site by controlling the energy of the pulsed electric field, causing irreversible electroporation damage to myocardial cells and achieving the therapeutic goal. This technology can effectively reduce the risk of thermal damage to surrounding normal tissues, benefiting more patients with drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation.

PFA field explosion
In recent years, PFA has rapidly become the mainstream ablation technique for treating atrial fibrillation due to its unique technological advantages. It is predicted that the global atrial fibrillation ablation market will double to 11 billion yuan by 2028. Among them, PFA's market share in atrial fibrillation ablation will also increase from less than 5% to over 60%.

According to Frost&Sullivan's prediction, the size of the PFA market in China is also continuously increasing, and it is expected to reach 1.3 billion yuan by 2025 and maintain rapid growth; By 2032, it is expected to increase to 16.3 billion yuan, with a compound growth rate of 43.73%. The proportion of PFA market size in the overall market size of electrophysiological devices in China is expected to continue to rise, increasing from 8% in 2025 to 39% in 2032.

With the gradual increase of market share, more and more innovative equipment companies are laying out in the PFA technology field, and have entered the harvest period in recent years. According to the China Listed Device Screening System database, NMPA has approved the listing of PFA products from 9 companies, including 6 local companies (Jinjiang Electronics, Deno Electrophysiology, Huitai Medical, Aptech Medical, Xuanyu Medical, Shanghai Hongtong) and 3 multinational companies (FARAPULSE, Medtronic, etc.) Biosense Webster）.

Among the aforementioned companies, FARAPULSE is a subsidiary of Boston Scientific, which was acquired in 2021; Biosense Webster is a subsidiary of Johnson&Johnson and was acquired in 1996.

Based on the continuously growing blue ocean market, Chinese PFA products have been intensively launched in the past two years. PFA products will begin to be approved in 2023, and officially enter the explosive period in 2024. The number of imported products approved in the middle of that year will be on par with local products, and 5 will be launched annually in 2024. Looking ahead to 2025, in March alone, four PFA products have been approved, and the number of approvals this year is expected to surpass the number approved in 2024.

In addition, it is worth mentioning that among the PFA products approved in China, the number of domestically produced products has surpassed the number of imported products. With the landing of more and more local enterprises focusing on the electrophysiological field, China's electrophysiological field has officially entered an explosive period, which is expected to break the current market competition pattern.

With the support of policies and the promotion of continuous technological development, the "gold content" of domestic medical devices is becoming increasingly high, and local medical devices are continuously shining with new brilliance.

Source: https://news.yaozh.com/archive/45230.html