Axonics® Receives IDE Clearance from U.S. FDA to Conduct a Pivotal Study with its Sacral Neuromodulation System for the Treatment of Urinary Dysfunction [translations pending]
Irvine, CA – Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) in accordance with 21 CFR 812 regulations allowing Axonics to conduct a pivotal study designed to gain FDA approval in the United States.
"During 2017, as part of the IDE process, the FDA conducted a significant review of our product. A major focus of the technical review was the long-term safety of our implant. The fact that we were able to support our anticipated 15-year full system life-in-the-body claim based on our robust design and development processes, risk analysis and extensive validation testing is testament to the high-quality work of our team," said Raymond W. Cohen, Chief Executive Officer of Axonics. "Given the demand in the U.S. market for SNM therapy, gaining FDA approval is our main focus. To that end, we fully intend to execute this well-designed pivotal study with velocity and in the best interests of patients."
Axonics expects to begin enrolling patients in the clinical study (ARTISAN-SNM) in November 2017, with a target of approximately 120 patients to be implanted at 15 centers of excellence located in the U.S. and Western Europe.
The ARTISAN-SNM study is a single-arm, prospective pivotal study designed to demonstrate the safety and effectiveness of the Axonics r-SNM system as an aid in the treatment of urinary urgency incontinence in patients who have failed or could not tolerate more conservative treatments.
Karen L. Noblett, M.D., Axonics Chief Medical Officer, stated, "The endpoints of the ARTISAN-SNM pivotal study are comparable to published clinical literature for urinary dysfunction. We will be analyzing, among other things, the proportion of responders to SNM therapy at six months post-implant based on reduction in urinary urgency incontinence episodes from the patient's baseline diary. There has been an overwhelming response from the Urology and Urogynecology community to be part of this pivotal study and, as a result, we have some of the most experienced and prolific implanters as study investigators."
During 2016, the Axonics r-SNM system gained regulatory approval in Europe and Canada for the treatment of overactive bladder, urinary urgency incontinence, urinary retention and fecal incontinence.