Affluent Medical completes pilot study for innovative urinary sphincter
January 31, 2025Affluent Medical, a French medtech company at the forefront of developing advanced implantable devices, has reached a key milestone in its mission to improve men’s healthas by successfully completing the pilot phase of its clinical study for the Artus system, an innovative artificial urinary sphincter (AUS) designed to treat stress urinary incontinence in men.
The pilot study cohort consists of ten men, with the primary objectives being device activation at six weeks after surgery and safety profile assessment at eight weeks, the company said.
The tenth implantation of the Artus artificial urinary sphincter was successfully performed in the second week of January 2025 in Poland, marking the end of patient enrollment for the pilot phase. The first patient was implanted in Q2 2024 at Thomayer University Hospital in Prague, Czech Republic, by Dr. Zachoval.
The device was implanted in 10 patients, with each procedure lasting approximately 40 minutes due to the innovative design of the Artus sphincter. To date, 100% of devices have been successfully activated and the safety profile remains positive.
“This first phase of the clinical study demonstrates the safety of the Artus device and the ease of use for minimally invasive procedure in men. All conditions are in line to continue the next phase of the clinical study”, emphasizes Prof. Nicolas Barry Delongchamps, Prof. of Urology, Cochin Hospital, Paris, and member of the Scientific Board of Affluent Medical.
The results from this initial clinical phase will guide the execution of the pivotal phase, scheduled to begin in Q2 2025. This phase aims to validate the device’s performance in reducing incontinence in several dozen patients.
“The completion of the pilot study for our Artus device marks an important milestone for Affluent Medical and patients suffering from urinary incontinence. The initial performance results are promising, enabling us to proceed to the pivotal phase to demonstrate these findings on a larger scale. As the safety profile is good, it is also an opportunity to start the clinical evaluation of the device in women, who represent about 80% of patients suffering from urinary incontinence”, said Sébastien Ladet, CEO of Affluent Medical.