FDA Approves Third Generation Model of Axonics’ Implantable Neurostimulator

The FDA has granted supplemental premarket approval for the third generation of Axonics’ implantable neurostimulator (INS) device.

The INS device is designed to treat urinary and bowel dysfunction. The third generation model includes upgraded software and functionality of the accompanying patient remote control, enabling patients to make more adjustments to the stimulation parameters at home.

The enhancements “provide an appropriate level of flexibility to maximize symptom relief as patients settle into their everyday lives,” the company said.