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Wednesday, September 22, 2021
HomeAxonics Modulation Technologies Inc.Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans

Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans

Axonics Modulation Technologies, Inc. announced it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (“MRI”) conditional labeling for the Axonics r-SNM® System. (Axonics Modulation Technologies (NASDAQ: AXNX) is a medical technology company focused on development and commercialization of novel Sacral Neuromodulation deices for treatment of urinary bowel dysfunction).

The company reports that the Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe1.

“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, said Raymond W. Cohen, Chief Executive Officer of Axonics.  He went on to say, “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.”

Full-body MRI labeling is a significant addition to the many differentiating attributes already offered by the Axonics r-SNM product: a miniaturized 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 Axonics r-SNM System also features, among other things, a fast and safe charging capability with an infrequent charging interval, and a patient-friendly wireless remote control.

“This is a game changer,” said Karen L. Noblett, M.D., Chief Medical Officer of Axonics. “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.”

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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