Axonics has announced that it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging conditional labelling for the Axonics r-SNM (sacral neuromodulation) system; a device used for the treatment of urinary and bowel dysfunction.
The Axonics r-SNM system is the only implantable SNM system that has received full-body MRI conditional labelling for sale in Europe.
Raymond W Cohen, CEO of Axonics, said, “Without this labelling, 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 authorisation 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 12 February, Axonics submitted complete test data to the US Food and Drug Administration (FDA) for the purpose of gaining conditional full body magnetic resonance imaging labelling approval in the USA”
Karen L Noblett, chief medical officer of Axonics, reiterated: “Full-body MRI labelling is critical to patients who need, or may anticipate needing, magnetic resonance imaging. This new expanded labelling 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.”
The Axonics r-SNM product also incorporates a miniaturised and long-lived implantable neurostimulator that is one-third the size of the only competitor and is qualified to last at least 15 years in the body. The system also features a fast and safe charging capability with an infrequent charging interval, and a patient-friendly wireless remote control.