Axonics Modulation Technologies (NSDQ:AXNX) said today that it submitted an amendment to the FDA premarket approval application for its implantable r-SNM System 1 Sacral Neuromodulation device seeking full-body magnetic resonance imaging labeling.
The amendment comes backed by complete test data which will support full body conditional labeling for 1.5 Tesla MR scanners, the Irvine, Calif.-based company said
The device already has approval for head and neck MR scans in Europe, Canada and Australia, while full-body CE Mark approval in the European Union is currently pending.
“Without this full body labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator and lead surgically explanted prior to the MRI scan, resulting in loss of an effective treatment, another surgery for the patient and additional cost to the patient and healthcare system. Our robust testing and analyses conclude that full body MRI scans can be safely performed on patients with an implanted Axonics r-SNM system. We met with the FDA in January 2019 and determined it was advantageous to file an amendment to the current literature-based PMA. The FDA now has all of our MRI test data for both head and full body and we believe that, once PMA approved, our r-SNM System will include conditional labeling for 1.5T MRI scans,” CEO Raymond Cohen said in a prepared statement.
Last month, Axonics said that it submitted interim clinical data from the pivotal study of its implantable sacral neuromodulation system to the FDA.