Axonics Modulation Technologies, Inc. Receives Marketing Approval from the Australian Department of Health for the First Rechargeable Sacral Neuromodulation (r-SNM™) System
January 08, 2018 at 08:00 am
Axonics Modulation Technologies, Inc. announced that it received marketing approval from the Australian Department of Health, Therapeutic Goods Administration (TGA) for the first rechargeable Sacral Neuromodulation (r-SNM™) System® to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention. This approval confirms that the Axonics r-SNM System meets all of the Australian Medical Devices Regulations for Active Implantable Medical Devices and enables commercialization throughout Australia. Over five million people, or approximately 20% of the Australian population, experience bladder or bowel control problems, many of which are not provided with a suitable therapeutic option. Urinary incontinence tops the list with up to 37% of women affected.