Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), 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, today announced completion of 1-year follow-ups and top-line clinical results from its ARTISAN-SNM pivotal clinical study conducted under an U.S. Food & Drug Administration (“FDA”) Investigational Device Exemption (“IDE”) designed to evaluate the safety and efficacy of the Axonics r-SNM® System1.
The study results at 1-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 1-year, 89% of all implanted subjects were therapy responders, consistent with the 90% therapy responder rate reported at 6-months. There were no serious adverse device related events or unanticipated device related events. The results at 1-year show consistent symptom decrease, quality of life improvement, and patient satisfaction as the previously reported 6-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 to be presented at the American Urogynecologic Society (AUGS), International Urogynecological Association (IUGA) congress being held from September 24 – 28, 2019 in Nashville.
ARTISAN-SNM: 1-Year Responder Rate
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 U.S. 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 3-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% reduction in urinary urgency incontinence episodes compared to baseline. An as-treated analysis was performed for all patients. At 1-year, 89% of all implanted subjects were therapy responders.
1 The Axonics r-SNM System is currently under PMA review by the FDA and designated as an investigational medical device