Axonics Modulation Technologies, a US-based medical technology company, has announced the results from its ARTISAN-SNM study, published online in the peer-reviewed Journal of Urology.
Axonics is engaged in the development and commercialization of implantable Sacral Neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction.
The company said that the study marks the first journal publication to underline outcomes for US patients treated with a rechargeable sacral neuromodulation system.
The study was conducted under a US Food & Drug Administration (FDA) Investigational Device Exemption (IDE), and showed that 90% of all patients implanted with the Axonics r-SNM System had positive therapy outcomes.
ARTISAN-SNM study investigator and urogynecologist Rebecca McCrery said: “The ARTISAN-SNM results provide the highest response rate for Sacral Neuromodulation seen in the clinical literature. These results are reflective of the benefits of the Axonics miniaturized rechargeable system and recent improvements in Sacral Neuromodulation techniques.
“Publication of the results in the Journal of Urology underscores the quality of the study and the interest among the physician community in innovative treatment options for patients suffering from urinary incontinence and bowel dysfunction.”
The ARTISAN-SNM study is aimed at evaluating the safety and efficacy of the Axonics r-SNM System in 129 patients suffering from Urinary Urgency Incontinence.
The 6-month study results show that 90% of the treated patients were therapy responders, defined as a ≥50% reduction in urgency incontinence episodes compared to their baseline.
In addition, the urgency incontinence episodes among the patients reduced from an average of 5.6 per day to 1.3 per day, and 80% of the patients had ≥75% reduction in their urgency incontinence episodes, and 34% were dry, with a 100% reduction.
The study results also revealed that patients have experienced a clinically meaningful improvement in the quality of life as indicated by a 34-point improvement in their ICIQ-OABqol score, and 93% of treated patients are happy with their r-SNM therapy while 98% said their charging experience was acceptable.
Axonics CEO Raymond W. Cohen said: “The Journal of Urology is the official journal of the American Urological Association and is widely read and cited. Publication in this peer-reviewed journal means the ARTISAN-SNM results are now available to current SNM implanters and the urology community at large.
“As we anticipate FDA approval in the United States in the coming months, this publication will be an aid in helping us reach our target clinical audience regarding the performance of the Axonics r-SNM System.”