Axonics Modulation Technologies has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (MRI) conditional labeling for the Axonics r-SNM system, which is claimed to be the only implantable sacral neuromodulation (SNM) system that secured full-body MRI conditional labeling for sale in Europe.
Axonics is a medical technology company contributing for the development and commercialization of novel implantable SNM devices to treat the urinary and bowel dysfunction.
SNM therapy is a treatment that has been widely employed to reduce symptoms and restore bladder function and treat urinary retention and fecal incontinence.
Axonics CEO Raymond Cohen said: “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.”
Full-body MRI labeling is an important addition to the attributes offered by the Axonics r-SNM product, including a miniaturized and long-lived implantable neurostimulator, that is qualified to last approximately 15 years in the body.
Axonics said that its r-SNM System also feature, a fast and safe charging capability with an infrequent charging interval, and a patient-friendly wireless remote control.
Axonics chief medical officer Karen Noblett said: “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.”
Recently, Axonics has submitted the complete test data to the US Food & Drug Administration (FDA) to secure conditional full body magnetic resonance imaging (MRI) labeling approval for its sacral neuromodulation system.
Cohen added: “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 US.”