Clinical trials

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.

This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking. The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases: * pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites), * pivotal phase (in up to 16 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety), * long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites). The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.