Axonics Modulation Technologies said today it won Health Canada approval for its rechargeable Sacral Neuromodulation System designed to treat overactive bladder, fecal incontinence and urinary retention.
The Irvine, Calif.-based company said it expects to be treating patients with the device during the 1st quarter of this year.
“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 2 large international territories. Additionally, we anticipate IDE clearance from the US FDA to treat patients in the US in the near term. 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,” CEO Raymond Cohen said in a press release.
Axonics said it previously had ethics committee approval from the University of Toronto to treat patients in Canada as part of a post-market clinical follow-up study.
Last June, Axonics said it launched the Relax-OAB 65-patient post-market clinical follow-up study of its SNM system designed to treat overactive bladder.
The SNM rechargeable neuromod system is designed to treat overactive bladder, urinary retention and fecal incontinence through sacral nerve stimulation, the company said.
Axonics touted the 1st implants and enrollments in the study, which took place at London’s National Hospital for Neurology and Neurosurgery and the Netherlands’ Maastricht University Medical Centre.
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