Health Canada Approves Full-Body MRI Labeling for the Axonics Sacral Neuromodulation System

Axonics Modulation Technologies Inc., a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (r-SNM) devices for the treatment of bladder and bowel dysfunction, announced that Health Canada has approved the use of full-body magnetic resonance imaging (MRI) using 1.5 and 3 Tesla MRI scanners for patients implanted with the Axonics r-SNM System.
 
Axonics previously received Health Canada approval for its complete r-SNM System and related system components in January 2017 and has been marketing in Canada since 2018. The U.S. Food and Drug Administration approved the Axonics r-SNM System for full-body MRI scans for 1.5 Tesla MRI scans in September 2019.
 
Raymond W. Cohen, CEO of Axonics, commented, “Allowing full-body MRI scans for Canadian patients means that none will have to undergo an explant of their neurostimulator device should they require an MRI. This approval underscores the commitment of Axonics to all patients in North America.”

Axonics, based in Irvine, Calif., has developed and is commercializing implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the United States and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the United States and Europe. The Axonics System is the first rechargeable SNM system approved for sale in the United States, Canada, and Europe and the first to gain full-body MRI conditional labeling.