World's First Bladder Tumor Cryoablation Medical Device Receives Market Approval

Source: SensCure　

Date: Jul. 5, 2022　

Views: 4,789

Recently, the innovative cryoablation system independently developed by SensCure Biotech (Ningbo) Co., Ltd.—comprising the Disposable Cryoablation Balloon Catheter and the Cryoablation Equipment—received successive market approvals from the National Medical Products Administration (NMPA) (Registration Nos.: Guo Xie Zhu Zhun 20223010763; Guo Xie Zhu Zhun 20223010768). The product entered the National Special Approval Channel for Innovative Medical Devices in June 2016 and possesses independent intellectual property rights.

The SensCure cryoablation system is indicated for the treatment of bladder tumors in combination with transurethral resection of bladder tumor (TURBt). It represents the world's first cryoablation medical device specifically developed for bladder tumors. Currently, the standard treatment protocol for bladder tumors is TURBt. Studies indicate that for non-muscle-invasive bladder tumors, the residual tumor rate following initial resection can range from 36% to 86% [1]. The SensCure cryoablation system provides a novel therapeutic modality for bladder tumors, effectively mitigating tumor residuals caused by incomplete resection during TURBt, thereby reducing the risk of tumor recurrence and/or progression.

The SensCure cryoablation system employs liquid nitrogen as the cryogen, featuring deep and extensive ablation capabilities. It effectively eradicates residual tumor cells at the tissue base while preserving the integrity of the bladder wall and avoiding complications such as bladder perforation.

Bladder tumor cryoablation marks the first approved indication within SensCure's comprehensive cryoablation product portfolio, representing a significant milestone. Moving forward, SensCure will focus on natural orifice transluminal endoscopic surgery (NOTES) technologies, further increase resource investment, and continue to introduce a series of innovative products.

1. Cumberbatch M, et al. Repeat Transurethral Resection in Non-muscle-invasive Bladder Cancer: A Systematic Review. European Urology 73:925–933, 2018.