Axonics Modulation Technologies has received CE Mark approval for use of its Axonics r-SNM implantable sacral neuromodulation (SNM) device for the treatment of urinary and bowel dysfunction in patients undergoing full-body 1.5- and 3-tesla MRI scans.
Axonics r-SNM currently is approved for use in patients receiving head and neck MRI scans in Europe, Canada, and Australia.
The new CE Mark approval extends that MRI-conditional labeling to patients undergoing full-body MRI scans, giving more flexibility to patients who choose SNM to treat urinary and bowel dysfunction without compromising their quality of life, according to the company.
