Axonics Modulation Technologies Inc. said the U.S. Food and Drug Administration approved its device to treat urinary and bowel dysfunction.
The process when a device is implanted in one's body to release low electrical stimulation targeting the sacral nerve is called sacral neuromodulation, or SNM. It is estimated that about 87 million adults in the U.S. and Europe are affected by an overactive bladder and another estimated 40 million adults are reported to have fecal incontinence. Sacral neuromodulation significantly helps such patients.
The Irvine, Calif.-based healthcare equipment company has developed Axonics r-SNM system, which is approximately the size of a USB stick, to specifically treat fecal incontinence. It is the first SNM device that can be recharged and need not be removed while undergoing an MRI scan.
Axonics r-SNM system, expected to function 15 years in the body, is the first rechargeable SNM system approved for sale in the U.S., Europe, Canada and Australia.
"We plan to begin shipping product to U.S. physicians and hospitals during the fourth quarter of 2019, following the fulfillment of customary, pre-launch regulatory requirements," Axonics CEO Raymond Cohen said in a press release.
The FDA approval is based on a clinical study, dubbed Artisan-SNM 129, where all the objectives of the trial were met.
Axonics also has a pre-market approval application under review with the FDA for the device to treat overactive bladder and urinary retention.
