Axonics, a company that has developed implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has announced US Food and Drug Administration (FDA) approval of its new wireless patient Remote Control with SmartMRI technology for the Axonics r-SNM system under a premarket approval (PMA) supplement.
According to the news release, the new Remote Control simplifies the process by which patients can receive a full-body MRI. An MRI technician can perform a simple check using a patient’s Remote Control immediately prior to an MRI, avoiding the need for the patient to visit their implanting physician’s office or involving personnel from Axonics. The new patient Remote Control with SmartMRI technology will be included in all new orders of the Axonics r-SNM System in the USA beginning this month.
The Axonics r-SNM system is approved for 1.5T full-body MRI scans in the USA and both 1.5T and 3.0T full-body MRI scans in Canada and Europe. In April 2020, Axonics submitted a PMA supplement to the FDA for the purpose of gaining full-body MRI conditional labelling for 3.0T MR scanners in the USA. The FDA review of this expansion of labelling is expected to be completed in early Q4 2020.
Raymond W Cohen, CEO of Axonics commented, “The introduction of this new patient Remote Control provides for significant convenience and reduces the burden on physician practices. This FDA approval follows the recent approval of both our next generation implantable neurostimulator and programmer and is part of a cadence of product enhancements that we are committed to pursuing.”