Axonics announced the presentation of detailed one-year results from its ARTISAN rechargeable sacral neuromodulation (r-SMN) pivotal study at a plenary session at the joint scientific meeting of the American Urogynecologic Society (AUGS) and the International Urogynecological Association (IUGA). The presentation of positive data, as well as numerous launch activities, highlighted Axonics’ first scientific meeting following the US Food and Drug Administration (FDA) clearance of the Axonics r-SNM System1 in September 2019.
During the meeting, more than 350 physicians of the approximate 2,000 at the conference, attended a one-hour symposium at which experienced physician implanters from the ARTISAN-SNM pivotal study discussed their first-hand impressions of the Axonics r-SNM System and post-implant patient feedback. In addition, more than 550 urologists and urogynecologists from the USA and abroad, visited Axonics’ exhibit and requested follow-up contact from the company.
ARTISAN-SNM study results were presented on September 28 at a plenary session by Felicia Lane, vice chair, Clinical Affairs, OBGYN, School of Medicine at the University of California, Irvine. The presentation, entitled, “Treatment of urinary urgency incontinence with the Axonics miniaturised, rechargeable SNM system: Clinical outcomes of the ARTISAN-SNM pivotal study,” summarised the clinical study 12-month outcomes demonstrating that patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life.
The ARTISAN-SNM study is a 129-patient single-arm, prospective, multicentre, unblinded pivotal clinical study approved under a US FDA investigational device exemption to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction. The study was conducted in 14 centres in the US and five centres in Western Europe. Top-line data was previously released in August 2019.
Key results at 12 months included
- 89% of the treated patients were therapy responders, defined as a ≥50% reduction in urgency incontinence episodes compared to their baseline. These results are consistent with the six-month results.
- Urgency incontinence episodes across all patients reduced from an average of 5.6 per day at baseline to 1.3 per day at six months
- 77% of the therapy responders had ≥75% reduction in their urgency incontinence episodes, and approximately 30% were dry, having experienced a 100% reduction
- Patients experienced a clinically meaningful improvement in quality of life as indicated by a 34-point improvement in their ICIQ-OABqol score
- 93% of treated patients were satisfied with their r-SNM therapy and 98% said their charging experience was acceptable
- 124 of the 129 patients remained in the study at one-year post-implant
- There were no serious device-related adverse events
“AUGS/IUGA was the first major medical conference at which our US commercial team was on hand to present our system and meet physicians who are experienced at implanting SNM devices a key milestone and a truly successful event for Axonics,” said Raymond W Cohen, chief executive officer. “The presentation of comprehensive one-year clinical results, which highlighted clinically significant symptom relief to patients, was also well received by the audience of health care providers.”