Health Canada approves full body MRI labeling for the Axonics Sacral Neuromodulation System
Axonics Modulation Technologies, 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, today announced Health Canada (Homologation d’un instrument medical) 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 & 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.”