Axonics Modulation Technologies (NSDQ:AXNX) said today that it won expanded CE Mark approval clearing its r-SNM Sacral Neuromodulation system for use with 1.5T and 3T full body magnetic resonance imaging.
The Irvine, Calif.-based company touted the r-SNM as the only implantable SNM system to have received full-body labeling in the EU.
“Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our technology from the competitive system and further demonstrating the foresight of our engineers and our commitment to invest the time and capital to provide the best possible SNM solution for patients, clinicians and the healthcare system. As announced on February 12, Axonics submitted complete test data to the U.S. FDA for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval in the U.S,” CEO Raymond Cohen said in a prepared statement.
“This is a game changer. Full-body MRI labeling is critical to patients who need, or may anticipate needing, magnetic resonance imaging. This new expanded labeling eliminates a major concern for both groups of patients and will allow more patients to choose SNM to treat their urinary and bowel dysfunction without compromising their quality of life,” chief medical officer Dr. Karen Noblett said in a press release.
Earlier this month, Axonics said 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.