MetaMedical™ Solutions Inc

Axonics secures Australia’s TGA approval for F15 SNM system

Medical technology company Axonics has announced receipt of Australia’s Therapeutic Goods Administration’s (TGA) approval for its Axonics F15 recharge-free sacral neuromodulation (SNM) system.

Designed to treat adults with overactive bladder, the Axonics F15 SNM system features a relatively small and thin implantable neurostimulator (INS), which has a volume of only 10cm³.

The device has a primary cell battery with an expected lifespan of over 15 years at typical stimulation parameters and potentially more than 20 years at lower settings.

Its constant current stimulation capability allows for automatic adjustments to maintain symptom relief with minimal reprogramming.

Axonics CEO Raymond W Cohen said: “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.”

The F15 system is MRI-compatible with both 1.5T and 3.0T whole-body MRI scanners. It also features an intuitive, easy-to-use recharge-free patient remote control.

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Calvary North Adelaide Hospital urologist Dr Ailsa Wilson Edwards said: “I am excited to offer my patients a recharge-free option that significantly increases device longevity compared to legacy technology, provides constant current stimulation, and utilises a simple remote control that is recharge-free and easy for patients to use.”

Earlier this year, Boston Scientific agreed to Axonics in a deal valued at approximately $3.7bn to expand its urology portfolio.

In addition to the F15 system, Axonics offers the R20 system to deliver sacral neuromodulation therapy and the Bulkamid urethral bulking system to treat female stress urinary incontinence.

Axonics is focused on developing and commercialising devices for the treatment of urinary and bowel dysfunction.

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