Axonics Announces One-Year Clinical Results from its ARTISAN-SNM Pivotal Study

Axonics Modulation Technologies Inc., a medical technology company that has developed and is commercializing a novel implantable Sacral Neuromodulation (SNM) device for the treatment of urinary and bowel dysfunction, has completed one-year follow-ups and announced clinical results from its ARTISAN-SNM pivotal clinical study conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) designed to evaluate the safety and efficacy of the Axonics r-SNM System.1
 
The study results at one year 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 one year, 89 percent of all implanted subjects were therapy responders, consistent with the 90 percent therapy responder rate reported at six months. There were no serious adverse device related events or unanticipated device related events. The results at one year show consistent symptom decrease, quality of life improvement, and patient satisfaction as the previously reported six-month study results.
 
Karen Noblett, M.D., chief medical officer of Axonics said, “The responder rate from the ARTISAN-SNM study is the highest success rate reported in SNM literature and confirms sustained efficacy. Analyzing all implanted subjects is the most rigorous form of data analysis and makes the results that much more impressive.”
 
Detailed study results are planned being presented this week at the American Urogynecologic Society (AUGS), International Urogynecological Association (IUGA) congress being held in Nashville, Tenn.
 
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. An as-treated analysis was performed for all patients. At one year, 89 percent of all implanted subjects were therapy responders.
 
Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 87 million adults in the United States and Europe. OAB is caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. SNM therapy is a well-established treatment that has been widely employed to reduce symptoms and restore bladder function and is also employed to treat urinary retention and fecal incontinence. Reimbursement for SNM is well established in the United States and is a covered service in Europe, Canada, and Australia.
 
Axonics, based in Irvine, Calif., is focused on the development and commercialization of implantable SNM devices for patients with urinary and bowel dysfunction. The Axonics r-SNM System is the first rechargeable sacral neuromodulation system approved for sale in Europe, Canada, and Australia and the first SNM system to gain full-body MRI conditional labeling in Europe.

Reference
¹ The Axonics r-SNM System is currently under PMA review by the FDA and designated as an investigational medical device