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Axonics® Receives FDA Approval for Recharge-Free Sacral Neuromodulation System
March 7, 2022
IRVINE, Calif.--(BUSINESS WIRE)--Mar. 7, 2022-- Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has approved its newly developed, long-lived, recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS).
The Axonics F15™ recharge-free SNM system has the following key attributes:
- INS type: primary cell battery
- INS longevity: functional life has been validated for over 15 years at typical stimulation parameters and over 20 years at lower energy settings
- INS volume: 10 cubic centimetres (20% smaller than the market’s other non-rechargeable SNM device)
- Stimulation: constant current automatically adjusts stimulation output
- MRI compatibility: full body with 1.5T and 3.0T whole-body scanners
- Patient remote control: intuitive, recharge-free key fob featuring SmartMRI ™technology
- Programming: proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses
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