The FDA has granted approval for Axonics Modulation Technologies’ rechargeable sacral neuromodulation device to treat bowel dysfunction (an additional premarket approval filing has already been submitted to the FDA for overactive bladder and urinary retention). The tiny neurostimulator can be recharged wirelessly through the skin, and includes a patient remote control and a programmer for clinicians to facilitate lead placement and stimulation. By delivering electrical stimulation to the body’s sacral nerve, the device aims to correct erroneous signals sent between the bowels, bladder and brain. The company also said the r-SNM system has a functional life of 15 years and is compatible with full-body MRI scans.
“FDA approves Axonics’ r-SNM system“
Chief Executive Officer of Axonics, Raymond Cohen, said: “We believe the number of patients seeking SNM treatment will expand dramatically over the next few years given our fuss-free, long-lived, full-body MRI-compatible device. In the months prior to FDA approval, we invested significant time and resources in building inventory to support our fully trained, U.S. commercial team which now includes 145 territory managers, clinical support specialists and sales managers strategically located around the country. We plan to begin shipping product to U.S. physicians and hospitals during the fourth quarter of 2019, following the fulfilment of customary, pre-launch regulatory requirements.”