The Irvine, Calif.-based company’s r-SNM system is an implantable sacral neuromodulation (SNM) device for treating urinary and bowel dysfunction. Its most recent regulatory win came in January when the FDA approved a second-generation programmer for the device.
Today’s FDA nod, under a premarket approval supplement, is for the next-generation implantable neurostimulator (INS) designed to decrease how frequently a patient needs to charge their implanted device.
Previously, the device required recharging for one hour every two weeks, but the new feature reduces that to once a month for one hour. It also gives patients the option to customize charging, like choosing to charge for only 15 minutes once a week or one hour every two months for patients with lower stimulation intensity levels.
The enhanced INS is also designed so that there is virtually no battery degradation over the 15+ year life span of the implant, thanks to the reduced charging burden.
Axonics said in a news release that it expects the next-generation INS device to begin shipping to customers in the U.S. during the third quarter of 2020.
“This FDA approval is another example of our commitment to innovation and to creating awareness, particularly among middle-aged women, that sacral neuromodulation is a safe and efficacious treatment for bladder and bowel dysfunction,” Axonics CEO Raymond Cohen said in the release. “We will continue to innovate by adding new embodiments and capabilities to our SNM product offering as well as working with the FDA to expand clinical indications.”