The Irvine, Calif.-based company submitted a supplement to the FDA regarding the use of full-body MRIs in its Artisan-SNM 129-patient pivotal trial. The FDA, which is evaluating Axonics’ device via the PMA pathway, concluded that the company provided sufficient data to support full-body MRIs.
Axonics touted its device as the first rechargeable sacral neuromodulation system available for sale in Europe, Canada and Australia. The system is roughly the size of a USB stick and can last at least 15 years in the body, according to Axonics.
“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,” CEO Raymond Cohen said in prepared remarks. “Given this approval, we are confident that this capability will be included as part of the Axonics SNM System premarket approval approval (sic), which is anticipated in the second half of 2019.”
The company is studying its device as a treatment for overactive bladder, which it estimates affects roughly 85 million adults in the U.S. and Europe. Last month, Axonics presented six-month data from its pivotal IDE study.