Axonics have announced that the Food & Drug Administration (FDA) approved the use of full-body magnetic resonance imaging (MRI) using 1.5 Tesla MRI scanners for clinical study patients implanted with the Axonics System.
The approval was a result of a supplement filed by Axonics with the FDA under the Investigational Device Exemption (IDE) regarding the company’s ARTISAN-SNM (sacral neuromodulation) 129-patient pivotal clinical study. The FDA concluded that Axonics provided sufficient data to support full-body MRIs.
Raymond W Cohen, CEO of Axonics, commented, “Allowing full-body MRI scans for our clinical study patients means that none will have to undergo an explant of their neurostimulator device should they require an MRI. We view this as a very positive step by the FDA that underscores the quality of data that Axonics has submitted to the agency. Given this approval, we are confident that this capability will be included as part of the Axonics SNM system premarket approval approval, which is anticipated in the second half of 2019.”
The Axonics System is the first rechargeable SNM system approved for sale in Europe, Canada and Australia and is currently under premarket approval review by the FDA. Axonics offers a long-lived miniaturised neurostimulator that is approximately the size of a USB stick and is qualified to last at least 15 years in the body, as compared to the only competitive device on the market from Medtronic, which requires replacement every three to five years. The Axonics System also features many other differentiating attributes, including a patented tined lead, a wireless charging system optimised for infrequent charging, a key fob size easy-to-use patient remote control and an intuitive clinician programmer that facilitates lead placement and stimulation programming.