Axonics Sacral Neuromodulation for Urinary and Fecal Dysfunctions Cleared for MRI in Europe

Implanting a medical device often means giving up the opportunity to receive MRI scans in the future. This can be particularly true of complex electronic implants that may be negatively influenced by strong magnetic fields. Things are changing, though, as companies are engineering a way out of this dilemma. Axonics, based in Irvine, California, won European regulatory approval for MRI conditional labeling for its sacral neuromodulation (SNM) system for treatment of overactive bladder, urinary retention, and fecal incontinence. The Axonics SNM system is now compatible, given certain precautions, with 1.5 Tesla and 3 Tesla MRI scanners. It is the only SNM system cleared in Europe with such labeling.
The implant is rechargeable, and so can be used for much longer periods than similar devices that have to be replaced with fresh batteries. The company promises a lifetime of up to 15 years, Axionics claims is three times longer than Medtronic’s InterStim. Additionally, it’s 60% smaller.