Axonics Modulation Technologies has received premarket approval from the Food and Drug Administration (FDA) for Axonics r-SNM System, an implantable sacral neuromodulation device (SMN), for the treatment of overactive bladder (OAB) and urinary retention.
The Axonics r-SNM System includes a neurostimulator, patented tined lead, remote control, and a charging system. The small, neurostimulator is implanted through a minimally invasive outpatient procedure. It delivers a constant current to the patient to maintain stimulation in the optimum therapeutic range with 15 years of functional life.
Once implanted, a clinician programmer facilitates lead placement and stimulation programming. Patients will be able to increase or decrease stimulation using the pocket-sized, easy-to-use remote control. The implant is charged wirelessly through the skin every 1 or 2 weeks for an hour or less. The SMN device has also been approved for patients undergoing full-body MRI scans without the need for removal.
The approval was supported by data from the pivotal ARTISAN-SNM clinical study that evaluated the safety and efficacy of the Axonics r-SNM System in the treatment of urinary urgency incontinence symptoms in 129 patients. The primary end point was the proportion of patients with ≥50% reduction in symptoms at 6 months; secondary end points included the ICIQ-OAB-qol (International Consultation on Incontinence Modular Questionnaire-OAB-Quality of Life) score, and the number of leaks and voids at 6 months.
Results demonstrated that the study met the primary and all secondary end points with 90% of patients responding to therapy at 6 months. Moreover, efficacy remained consistent at 1 year with an 89% responder rate. A majority of implanted patients experienced a significant reduction in urgency incontinence episodes with approximately one third of patients being completely dry. Regarding safety, no serious device-related adverse events were reported.
Commenting on the approval, Raymond W. Cohen, CEO of Axonics said, ”Based on feedback from US physicians, we believe the SNM market is poised to dramatically expand over the next few years given our fuss-free, highly efficacious, long-lived, full-body MRI compatible device.”
In addition to the OAB and urinary retention indications, the device was recently approved for treating fecal incontinence.
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