First Implants With New Recharge-Free Sacral Neuromodulation System

Axonics Inc. is touting the first patient implants of its newly developed, long-lived, fully recharge-free sacral neuromodulation (SNM) system, the Axonics F15. 

The University of Alberta, Canada, implanted four patients last month with the Axonics F15. The four patients were programmed at stimulation amplitudes between 0.95mA and 0.30mA, resulting in an expected battery longevity in the body ranging from 18 years to over 22 years.

“The approval of the Axonics recharge-free system is welcome news for patients in Canada suffering from bladder and bowel dysfunction,” said Gary J. Gray, M.D., FRCS, a urologist and clinical professor at the Kipnes Urology Centre in the Department of Surgery at the University of Alberta. “I am excited to now offer patients a recharge-free option that significantly increases device longevity in the body alongside the rechargeable Axonics SNM system that has helped so many of my patients.”
 
The Axonics F15 received regulatory approval from Health Canada following U.S. Food and Drug Administration approval, and was launched in the United States in Q2. 

The Axonics F15 SNM system utilizes a recharge-free implantable neurostimulator (INS) that is relatively small and thin at only 10 cubic centimeters in volume. The INS employs a primary cell battery and has an expected life in the body of more than 15 years at typical stimulation parameters and more than 20 years at lower energy settings. Constant current stimulation allows the device to automatically adjust the magnitude of stimulation to maintain symptom relief with minimal reprogramming. The F15 is MRI compatible with 1.5 and 3.0T whole-body MRI scanners and utilizes an intuitive, easy to use recharge-free patient remote control.
 
“Millions of adults in North America suffer from incontinence and struggle to find long-term symptom relief. SNM began experiencing a renaissance a few years ago when Axonics introduced the world’s first long-lived, miniaturized, full-body MRI compatible, rechargeable SNM system,” said Karen Noblett, M.D., FPMRS, chief medical officer of Axonics. “Similarly, our long-lived, fully recharge-free SNM system has the potential to increase adoption of SNM therapy and significantly improve the quality of life for adults with bladder and bowel dysfunction.”
 
Based in Irvine, Calif., Axonics is developing and commercializing products for adults with bladder and bowel dysfunction. Axonics sacral neuromodulation (SNM) systems provide patients suffering from overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s urethral bulking hydrogel, Bulkamid, provides safe and durable symptom relief to women with stress urinary incontinence (SUI). Overactive bladder affects an estimated 87 million adults in the United States and Europe, with an additional 40 million adults estimated to suffer from fecal incontinence. SUI affects an estimated 29 million U.S. women. Axonics’ products are offered at hundreds of U.S. and international medical centers.