The Food and Drug Administration (FDA) has approved a new version of Axonics Modulation’s rechargeable implantable sacral neurostimulator (r-SNM) system that allows patients to decrease the frequency of charging to once a month. The first iteration of the device was approved by the FDA late last year.
Axonics r-SNM system is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. It is also approved for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.
The small neurostimulator is implanted through a minimally invasive outpatient procedure. It delivers a constant current to maintain stimulation in the optimum therapeutic range with 15+ years of functional life. The device can be charged wirelessly through the skin once a month for about 1 hour. The user also has the option to recharge for 15 minutes once a week. Those who have lower stimulation intensity levels can charge for 1 hour every 2 months.
The next generation Axonics implantable neurostimulator is expected to be available in the US during the third quarter of 2020.
For more information visit Axionics.com.