Axonics F15 Recharge-Free SNM Nabs Australian TGA Approval
The F15 recharge-free sacral neuromodulation system is indicated for the treatment of adults with overactive bladder.
Axonics recently announced it has received regulatory approval from Australia’s Therapeutic Goods Administration (TGA) to market the Axonics F15 recharge-free sacral neuromodulation (SNM) system for the treatment of adults with overactive bladder.
The F15 SNM system uses a recharge-free implantable neurostimulator that is 10 cubic centimeters in volume. It has a primary cell battery and an expected life in the body of over 15 years at typical stimulation parameters and over 20 years at lower energy settings. Due to the device’s constant current stimulation, it automatically adjusts the “magnitude of stimulation to maintain symptom relief with minimal reprogramming,” according to Axonics.
Additionally, F15 is MRI compatible with 1.5 and 3.0T whole-body MRI scanners and uses a recharge-free patient remote control. The company reportedly began SNM commercial activities in Australia in March 2023.
“We are delighted to receive regulatory approval for our latest SNM system in Australia,” said Raymond W. Cohen, CEO of Axonics, in the press release announcing the regulatory victory. “Our mission-driven team remains committed to innovating, supporting our dedicated physician customers and their patients, and raising awareness of our best-in-class incontinence therapies in the United States, Europe and Australia.”
About the Author
You May Also Like