Antech Medical's Innovative Cryoablation Device Receives NMPA Approval

Aug 07, 2024 11:41 CST Updated 11:41

Artechmed

Medical Device and Equipment Developer

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Recently, the National Medical Products Administration approvedArtechmedInnovative Products"Balloon-type Cryoablation Catheter"The registration application. This year, Shanghai has approved the listing of 3 domestically produced Class 1 innovative drugs, 3 imported innovative drugs, and 6 Class III innovative medical devices. Among them, Zhangjiang Science City has approved the listing of 2 domestically produced Class 1 innovative drugs and 3 Class III innovative medical devices.

Artechmed's "Balloon-type Cryoablation Catheter" consists of a balloon-type cryoablation catheter and a manual retractor, and is used in conjunction with a specific cryoablation instrument to treat adult patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. The product’s “32mm large balloon” and “8mm short tip” design allows for stable control of refrigerant flow, effective control of freezing temperature, and can closely approach the pulmonary vein ostium to effectively capture pulmonary vein potentials, thereby ensuring the effectiveness of cryoablation. Compared to similar domestic and foreign products available in China, this technology is a first-of-its-kind innovation. The availability of this product can further meet clinical needs in the field of paroxysmal atrial fibrillation treatment in China.

Source: Shanghai Medical Products Administration

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