Antek Medical's Novel Cryoablation System with Proprietary Adjustable Cooling and Rewarming Alert Technologies Receives NMPA Approval

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Recently, the National Medical Products Administration approved the registration application for the "Cryotherapy Ablation System," an innovative product by Artechmed. This marks the second Class III innovative medical device approved in Shanghai this year and the third cryoablation innovation product developed independently in China to be marketed.

Compared with similar domestic and foreign products already on the market in China, the "adjustable cooling capacity" and "rewarming reminder" technologies used in this product are pioneering. See details below ↓

This product consists of a main unit, gas extension tube, and balloon catheter pigtail, and is used in conjunction with a specific balloon-type cryoablation catheter for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation in adult patients.

Compared with similar domestic and foreign products already on the market in China, the product’s use of "adjustable cooling capacity" and "rewarming reminder" technologies is a pioneering innovation. The "adjustable cooling capacity" technology can monitor the freezing temperature in real time, reducing damage to adjacent tissues while ensuring the effectiveness of cryoablation treatment. The "rewarming reminder" technology can reduce clinical and operational risks such as myocardial injury caused by premature balloon retraction and difficulty in retracting the balloon into the sheath.

The pharmaceutical regulatory authorities will strengthen the post-market supervision of this product to protect the safety of patients using medical devices.

This innovative medical device was developed in Zhangjiang International Medical Park. In August 2023, it entered the special review channel for national innovative medical devices. After obtaining approval, the product will be manufactured and supplied to the market in the city, serving as another typical case of "Zhangjiang R&D + Shanghai Manufacturing." In recent years, cryoablation has rapidly emerged in fields such as atrial fibrillation treatment, with several domestically developed cryoablation innovations successively receiving market approval.

For example, in August 2023, the National Medical Products Administration approved the registration application for the innovative products of the cryoablation device and balloon-type cryoablation catheter produced by Shanghai MicroPort EP MedTech Co., Ltd. These two products are used together for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation and are the first of their kind in China.

In December 2023, the National Medical Products Administration approved the registration applications for the innovative products "Cryotherapy Device" and "Balloon Cryoablation Catheter" produced by Kangfeng Biotechnology (Shanghai) Co., Ltd. These two products are used together in medical institutions to treat drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation, further meeting China's clinical needs in the field of paroxysmal atrial fibrillation treatment.

During the period from the development and application to the approval and market launch of the aforementioned multiple innovative cryoablation products, the Yangtze River Delta Branch of the National Medical Products Administration's Center for Medical Device Evaluation provided "one-on-one, zero-distance" consulting and guidance services through a dedicated mentoring mechanism for innovative products, offering on-site support to companies multiple times. The municipal drug regulatory bureau included the products in its pre-submission service recommendations. The municipal device evaluation center, the municipal medical device institute, and the Pudong New Area Biomedical Product Registration Guidance Service Workstation took proactive steps to assist by addressing bottlenecks and challenges encountered during product development, testing, and registration verification, helping enterprises avoid unnecessary detours.

This year, three domestically produced Class 1 innovative drugs, three imported innovative drugs, and two Class III innovative medical devices have been approved for marketing in Shanghai. Among them, Zhangjiang Science City has seen the approval of two domestically produced Class 1 innovative drugs and one Class III innovative medical device.

Source: Shanghai Medical Products Administration

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