Axonics Receives IDE Clearance from FDA for Sacral Neuromodulation System Study

Axonics Modulation Technologies Inc., developer of the first rechargeable sacral neuromodulation (r-SNM) system for the treatment of overactive bladder (OAB) and bowel dysfunction, said the U.S. Food & Drug Administration (FDA) has granted the company an Investigational Device Exemption (IDE) 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, CEO 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 began enrolling patients in the clinical study (ARTISAN-SNM) this month, with a target of approximately 120 patients to be implanted at 15 centers of excellence located in the United States 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.
 
Axonics, based in Irvine, Calif., is a privately-held venture backed company that has developed an implantable neuromodulation technology for patients with urinary and bowel dysfunction. The Axonics r-SNM system includes a miniaturized rechargeable implantable neurostimulator qualified to function at least 15 years in the body, a charging system optimized for reduced charge time with no heating, a patient-friendly remote control and an intuitive clinician programmer that facilitates the lead placement procedure and programming.