FDA Approves Axonics' Recharge-Free Sacral Neuromodulation System

The FDA has approved Axonics Inc's AXNX recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS).

  • The Axonics F15 recharge-free SNM system's functional life has been validated for over 15 years at typical stimulation parameters and more than 2 decades at lower energy settings.
  • INS volume: 10 cubic centimeters (20% smaller than the market's other non-rechargeable SNM device).
  • Constant current automatically adjusts stimulation output.
  • Related: US Patent Office Rejects Three More Axonics' Challenge To Medtronic Patents.
  • MRI compatibility: 1.5T and 3.0T whole-body scanners.
  • Patient remote control: intuitive, recharge-free key fob featuring SmartMRI technology.
  • A proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses.
  • The company expects to begin shipping the Axonics F15 system in April.
  • Price Action: AXNX shares closed 3.42% higher at $56.00 during after-hours trading on Monday.

Posted In: NewsHealth CareFDAGeneralBriefs