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Implantable Sacral Nerve Stimulation System Approved for Marketing

CCFDIE| Updated: 2023-06-14

Recently, three innovative products, the Implantable Sacral Nerve Stimulator, Implantable Sacral Nerve Stimulation Extension Wire and Implantable Sacral Nerve Stimulation Electrode of Hangzhou Chengnuo Medical Technology Ltd. are approved by China NMPA.

These three products are used together to form the implantable sacral nerve stimulation system, of which the core technology has independent intellectual property rights. The system can generate multiple stimulation pulse signals through the six sacral nerve stimulation contacts, and can realize the parameter regulation of stimulator in non-close contact by using the far field programmable communication technology. Moreover, the system, combined with six contact electrodes, can provide more combinations of stimulus, refine the regulatory range, and add treatment methods for lower urinary tract dysfunction, so as to further meet the clinical needs of patients.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.