Axonics Releases Tw-Year Clinical Results from ARTISAN-SNM Pivotal Study

Axonics Modulation Technologies Inc., a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has announced completion of two-year follow-ups and topline clinical results from its ARTISAN-SNM pivotal study that was conducted to evaluate the safety and efficacy of the Axonics r-SNM System.
 
The two-year study results demonstrate that patients implanted with the Axonics r-SNM System continue to receive clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life. At two years, 88 percent of all implanted patients were therapy responders, consistent with the 89 percent therapy responder rate reported at one year. Eighty percent of patients achieved >75 percent improvement, with 37 percent being completely dry. There were no serious adverse or unanticipated device related events.
 
“The responder rate from the ARTISAN-SNM study continues to be the highest success rate reported in SNM literature and confirms sustained efficacy,” said Karen Noblett, M.D., a board-certified urogynecologist and chief medical officer of Axonics. “Americans with urgency incontinence are undertreated and struggle to find long-term relief. The persistent robust response and patient satisfaction with the Axonics r-SNM System demonstrates that there is an easy to use, highly efficacious treatment available to those suffering from this condition.”

The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study to evaluate the safety and efficacy of the Axonics r-SNM System. The study was conducted in 14 centers in the United States and five centers in Western Europe. All patients diagnosed with urinary urge incontinence were implanted with a tined lead and the Axonics miniaturized rechargeable neurostimulator in a non-staged procedure. Efficacy data was collected using a three-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a subject satisfaction questionnaire. Therapy responders at follow-up were identified as patients with at least a 50 percent reduction in urinary urgency incontinence episodes compared to baseline. Completion of two-year follow-ups concludes the ARTISAN-SNM study.