Sam Brusco, Associate Editor02.16.21
Axonics Modulation Technologies, a firm that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices to treat of urinary and bowel dysfunction, received PMA supplement approval from the U.S. Food & Drug Administration (FDA) for its third-gen implantable neurostimulator (INS).
This is 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-gen rechargeable INS last April, extending the recharge interval to one hour each month.
The third-gen INS upgrades its embedded software and the patient remote control’s functionality. These modifications allow broader stimulation parameter adjustments at home, including selecting a second therapy program set post-operatively based on interoperative findings. These enhancements provide an appropriate level of flexibility to maximize symptom relief as patients settle into everyday lives.
Axonics expects to begin shipping the third-gen INS and patient remote control on March 1.
Raymond W. Cohen, CEO of Axonics, told the press, “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. 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.”
This is 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-gen rechargeable INS last April, extending the recharge interval to one hour each month.
The third-gen INS upgrades its embedded software and the patient remote control’s functionality. These modifications allow broader stimulation parameter adjustments at home, including selecting a second therapy program set post-operatively based on interoperative findings. These enhancements provide an appropriate level of flexibility to maximize symptom relief as patients settle into everyday lives.
Axonics expects to begin shipping the third-gen INS and patient remote control on March 1.
Raymond W. Cohen, CEO of Axonics, told the press, “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. 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.”