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.

Katie Hobbins, Managing Editor

May 17, 2024

1 Min Read
TGA approval
BrianAJackson / iStock / Getty Images Plus via Getty Images

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(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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