Axonics (Nasdaq:AXNX) today announced the first patient implants in Canada for its Axonics F15 sacral neuromodulation (SNM) system.
Irvine, California-based Axonics designed its new F15 as a long-lived, fully recharge-free SNM system. It received Health Canada approval after FDA approval in March. The company’s U.S. launch took place the following month.
According to a news release, the University of Alberta implanted four patients with F15 this week. The patients were programmed at stimulation amplitudes between 0.95mA and 0.30mA. The resulting expected battery longevity ranges from 18 years to more than 22 years.
“The approval of the Axonics recharge-free system is welcome news for patients in Canada suffering from bladder and bowel dysfunction,” said Dr Gary J. Gray, 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.”
What is the Axonics F15?
F15 uses a small and thin (10 cubic cm in volume) implantable neurostimulator. It employs a primary cell battery with an expected life in the body of over 15 years. Its typical stimulation parameters reach over 20 years at lower energy settings.
Constant current stimulation allows the device to automatically adjust the stimulation magnitude to maintain symptom relief with minimal reprogramming. F15 is MRI compatible with 1.5 and 3.0T whole-body MRI scanners. It uses a recharge-free patient remote control as well.
“Millions of adults in North America suffer from incontinence and struggle to find long-term symptom relief,” Axonics CMO Dr. Karen Noblett said. “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.
“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.”