Axonics Modulation Technologies has submitted an application to the U.S. Food and Drug Administration (FDA) to enable the company to add full-body MRI-conditional status to the regulatory labeling of its Axonics r-SNM sacral neuromodulation implants.
Axonics r-SNM is an implant that provides sacral neuromodulation for patients with urinary and bowel dysfunction. Axonics r-SNM currently is approved for use in patients receiving head and neck MRI scans in Europe, Canada, and Australia.
The new FDA filing would give Axonics regulatory approval to market the product for use with full-body MRI scans, as an amendment to the company's previously filed premarket approval (PMA) application. CE Mark approval of full-body MRI labeling is pending.
Without full-body labeling, patients requiring an MRI scan on any body part below the head must have their neurostimulator and lead surgically explanted prior to the MRI scan, explained Axonics CEO Raymond Cohen in a release. Such action could result in the loss of an effective treatment, another surgery for the patient, and additional cost to the patient and healthcare system.
