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Medical Devices / Submissions and Approvals

Axonics’ Sacral Neuromodulation System Gains Further Clearance

Feb. 26, 2019

Axonics received the CE Mark for full-body MRI conditional labeling for its sacral neuromodulation device, used to treat urinary and bowel dysfunction.

The device is the only implantable sacral neuromodulation device that has received full-body MRI conditional labeling for European marketing.

With the clearance, patients receiving an MRI scan anywhere below the head can avoid additional surgery, as they no longer need to have their neurostimulator explanted before they undergo the scan.

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