Axonics modulation technologies presents full one-year results from artisan-snm pivotal study at augs/iuga joint scientific meeting

Axonics modulation technologies reported the presentation of detailed one-year results from its artisan-snm 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 fda clearance of the axonics r-snm system1 in september 2019. the artisan-snm study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an 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 centers in the u.s. and five centers in western europe. top-line data was previously released in august 2019. according to a media release, 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.
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