US-based Axonics Modulation Technologies has obtained the European CE-Mark approval for magnetic resonance imaging (MRI) conditional labelling of its rechargeable Sacral Neuromodulation (r-SNM) System.
The labelling covers 1.5T and 3T full-body MRI, eliminating the need for patients to undergo surgical removal of their neurostimulator before undergoing an MRI scan on any part below the head.
Axonics r-SNM System received the initial CE-Mark in June 2016 to treat urinary and faecal dysfunction.
The first faecal incontinence patients were implanted at the University Hospital Southampton NHS Foundation Trust in the UK in December 2016.
Axonics Modulation Technologies chief medical officer Karen Noblett said: “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.”
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The Axonics r-SNM System is an implantable neuromodulation device that controls the sacral nerve activity to treat overactive bladders (OAB), faecal incontinence and urinary retention.
The miniaturised device is said to have the potential to last a minimum of 15 years in the body. It also features quick, safe charging capability and a patient-friendly wireless remote control.
Axonics Modulation Technologies CEO Raymond Cohen said: “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.”
The company is also seeking the US regulatory approval for full body MRI conditional labelling.