Antech Medical's Cryoablation System Becomes Shanghai's Second Class III Innovative Medical Device Approved This Year

Recently, the National Medical Products Administration approvedArtechmed "Cryotherapy Ablation System" Innovative ProductRegistration Application.

This isThe Second Class III Innovative Medical Device Approved in Shanghai This Year, marking the third domestically developed cryoablation innovation product approved for marketing in Shanghai.

(Image source: National Medical Products Administration)

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 "adjustable cooling capacity" and "rewarming reminder" technologies used in this product are pioneering.

"Adjustable cooling capacity" technology can monitor the freezing temperature in real time, reducing damage to adjacent tissues while ensuring the effectiveness of cryoablation treatment; "rewarming reminder" technology can reduce clinical and operational risks such as myocardial injury caused by premature balloon retraction and difficulty in balloon sheathing.

The drug regulatory department will strengthen the post-market supervision of this product to ensure patient safety in medical device usage.

"Cryogenic Ablation System" Innovative Product

This innovative medical device was developed in the Zhangjiang Science City Shanghai International Medical Park, entered the National Innovative Medical Device Special Review Channel in August 2023, and after being approved, will be produced and supplied to the Shanghai market. It is another typical case of "Zhangjiang R&D + Shanghai Manufacturing."

In recent years, cryoablation has rapidly emerged in fields such as atrial fibrillation treatment, and several innovative cryoablation products independently developed in Shanghai have been successively approved for marketing.

For example, in August 2023, the National Medical Products Administration (NMPA) approvedInnovative Products of Cryoablation Equipment and Balloon-Type Cryoablation Catheters Produced by MicroPort EPRegistration application: Two products used in combination for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. This is a first-of-its-kind innovation in China.

In December 2023, the National Medical Products Administration (NMPA) approvedCryogenic Ablation System and Balloon Cryoablation Catheter – Innovative Products Produced by Kangfeng BiotechnologyRegistration Application: Two products are used together in medical institutions for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation, further meeting the clinical needs in China for 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 guidance services through a dedicated mentoring mechanism for innovative products, offering on-site "one-on-one, zero-distance" consulting support to innovative enterprises on multiple occasions. The Shanghai Municipal Medical Products Administration included the products in the pre-submission service recommendation scope. The Shanghai Center for Medical Device Evaluation, the Shanghai Institute of Medical Devices, and the Pudong New Area Biomedical Product Registration Guidance Service Workstation took proactive steps to provide advanced services, collaboratively addressing bottlenecks and difficulties encountered by companies during the product development, testing, and registration inspection stages, helping enterprises avoid unnecessary detours.

This year, there are a total ofThree Class 1 innovative drugs produced in China, three imported innovative drugs, and two Class 3 innovative medical devicesApproved for marketing.

Shanghai's pharmaceutical regulatory authorities continue to enhance policy supply and innovation service capabilities, constantly improving the "one list, two optimizations, three linkages" service mechanism. They formulate a list of key development products and projects, and provide tiered and categorized service guidance based on the principle of "early involvement, dedicated personnel, full-process tracking, and professional guidance." By leveraging the frontline role of district-level biomedical product registration guidance service workstations, they actively identify and nurture innovative products through a combination of "municipal database establishment + district-level surveys." A dedicated medical device service window platform has been set up to track and support key projects, with designated personnel addressing specific corporate needs and guiding solutions to complex issues. For critical products during key periods, they implement a "one product, one company, one strategy" approach to enhance service relevance and effectiveness, accelerating the issuance of innovation product registration certificates in Shanghai. Through service-oriented regulation, they continuously foster a world-class business environment in the pharmaceuticals sector.