Xinuopu Medical's Innovative Single-Use Balloon Cryoablation Catheter Receives NMPA Approval

Recently, the National Medical Products Administration approved the registration application for the innovative product of Synaptic Medical Technology (Beijing) Co., Ltd.'s disposable balloon-type cryoablation catheter.

This product consists of a balloon-type cryoablation catheter and a manual retractor kit. It is used in conjunction with the cryoablation instrument produced by the same company, mainly for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation in adult patients.

The disposable balloon-type cryoablation catheter adopts a special fluid jet device and balloon pressure monitoring technology. The special fluid jet device ensures uniform temperature distribution on the surface of the front hemisphere of the balloon for effective ablation, while the balloon pressure monitoring technology ensures stable contact of the balloon and maintains stable internal pressure. This product effectively reduces the risk of balloon displacement due to pressure fluctuations during ablation, benefiting more patients with paroxysmal atrial fibrillation.
The drug regulatory department will strengthen the post-market supervision of the aforementioned products to ensure patient safety in medical device usage.

Source: National Medical Products Administration

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