The subjects will be implanted with the ARTUS® medical device and then be followed up to 2 years post-implantation, with the primary endpoints measured at 3-month post-implantation. Safety and Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.
Female subject over 18 years of age at the time of consent signature
at least 3 months after failed pelvic floor muscle training OR
at least 6 months after a failed surgical treatment (e.g. slings)
Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test > 100 grams
Subject currently enrolled or plans to participate in another investigational study of a drug, biologic, or medical device from the point of enrolment through the 12 months post device activation period
Subject deprived of liberty by administrative or judicial decision or under legal guardianship
Subject who is unwilling or deemed by the investigator to be unwilling to comply with the clinical study requirements, including attending follow-up visits.
Subject having inadequate cognitive or capabilities to use the Artus device as assessed by the investigator