FDA Approves Axonics R20 System for Bladder and Bowel Relief

The FDA has approved Axonics’ R20 neurostimulator, a fourth-generation implant for sacral neuromodulation, a therapy for overactive bladder and bowel incontinence.

The implant, which lasts at least 20 years, needs to be recharged once every six to 10 months for one hour, the company said.

Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, and fecal incontinence affects an estimated 40 million adults.

Irvine, Calif.-based Axonics plans on commercially launching the product in the U.S. in March.