Axonics Gets FDA Approval for Third-Generation Implantable Neurostimulator

 Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has received PMA supplement approval from the U.S. Food & Drug Administration (FDA) for its third-generation implantable neurostimulator (INS).

This marks the sixth FDA approval Axonics has received for a significant product innovation since the company’s U.S. commercial launch in November 2019. The FDA previously approved Axonics' second-generation rechargeable INS in April 2020, which extended the recharge interval to one hour each month.

The third-generation INS upgrades the embedded software in the INS and the functionality of the patient remote control. These modifications give patients the ability to make broader stimulation parameter adjustments at home, including selecting a second therapy program that was set post-operatively based on interoperative findings. These enhancements provide an appropriate level of flexibility to maximize symptom relief as patients settle into their everyday lives. This is accomplished while patients continue to benefit from an intuitive, easy to use therapy experience.

Axonics expects to begin shipping the third-generation INS and patient remote control on March 1, 2021.

https://www.biospace.com/article/releases/axonics-receives-fda-approval-for-third-generation-implantable-neurostimulator/