National List of Innovative Medical Devices - Single-use cryoablation balloon catheter
2021-11-09
On June 24, 2022, the information released on the website of the State Food and Drug Administration shows that the innovative medical device "disposable cryoablation balloon catheter" produced by Ningbo Shengjiekang Biotechnology Co., Ltd. was approved for listing, becoming the 27th innovative medical device approved in 2022.
Screenshot of the official website of the State Medical Products Administration
It is understood that the "disposable cryoablation balloon catheter" is composed of the balloon, the main body of the catheter (vacuum outer tube, vacuum inner tube, return tube, intake tube, buffer tube, protection tube) and the handle (handle seat, loop connecting tube, vacuum connecting tube, and joint). Used in conjunction with a specific cryoablation device for the adjuvant treatment of cryoablation in adult patients with stage T1 non-invasive bladder cancer (NMIBC) following initial transurethral resection of bladder tumors (TURBt).
At present, there are no bladder tumor freezing medical devices in China, domestic probe frozen medical devices are limited to the application of solid tumors, and imported balloon frozen medical devices are limited to the application of cardiovascular system. The core technology of the product is the innovative balloon structure design at the catheter head end, and the distal end of the balloon is concave, which can realize the effective freezing of the side and distal end of the balloon. A buffer unit is also designed at the distal end of the balloon, which can increase the safety of the product and facilitate the delivery of the catheter.
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