Axonics Modulation Technologies has secured medical device approval from Health Canada for its rechargeable sacral neuromodulation (r-SNM) system to treat overactive bladder (OAB), fecal incontinence and urinary retention.
Earlier, the firm received ethics committee approval from the University of Toronto for the system to treat patients in Canada, as part of its post-market clinical follow-up study.
The r-SNM system is an implantable neuromodulation system, which regulates sacral nerve activity to manage urinary and fecal dysfunction.
The system features miniaturized implantable pulse generator, as well as key-fob sized patient-friendly remote control and an advanced clinician programmer that will guide and support physician implanters across the procedure ranging from placement to programming.
Axonics plans to commercialise the system in the first quarter of this year.
According to the company, the OAB affects around 5 million adults in the US and Europe, and another 40 million are reported to suffer from fecal incontinence.
Axonics CEO Raymond Cohen said: “The Health Canada approval provides Axonics with another important marketing approval. Along with our European CE Mark, it gives us the ability to sell our r-SNM System in two large international territories.
“To date, Axonics has implanted nearly 40 patients in Europe with excellent clinical results. These results confirm that our miniaturized implantable neurostimulator is meeting its promise to advance the state of the art for sacral neuromodulation and improve the quality of life of patients suffering from urinary and fecal dysfunction.”