Axonics (NSDQ: AXNX) today said it received FDA PMA supplemental approval for its third-generation implantable neurostimulator.
The new iteration go the device upgrades the embedded software in the implantable neurostimulator (INS), as well as the functionality of the patient remote control. The modifications give patients the ability to make broader stimulation parameter adjustments from home. It also provides an appropriate level of flexibility to maximize symptom relief as patients settle into their everyday lives.
“This is another significant upgrade we have made to the Axonics System, underscoring our commitment to continuous innovation that enhances the patient experience. While our long-lived INS device is as close to a ‘set it and forget it’ therapy, the new features will benefit physician practices in which patients have to travel long distances should they require therapy adjustments,” CEO Raymond Cohen said in a news release. “We are confident that continuing to ensure excellent patient experiences will drive significant market expansion in the years ahead and result in SNM therapy becoming the preferred solution for urinary and bowel dysfunction.”
Axonics said it plans to begin shipping the third-generation INS and patient remote control on March 1.
