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The company was founded by Dr. Christophe Llorens and Raphael Llorens in 2005.[1] The first product – ZSI 375 artificial urinary sphincter, was introduced in 2009.[2][3] As of 2019, more than 4500 ZSI 375 artificial urinary sphincters were implanted worldwide.[2] The inflatable penile implant designed for female-to-male gender reassignment surgeries became available in the European market in March 2016, and the first phalloplasty procedures using ZSI 475 FtM implants were performed in June 2016.[4]
Many clinical studies have been performed with the artificial urinary sphincter ZSI 375 in the treatment of moderate and severe stress incontinence, most of them are retrospective and non-randomized tests. Success rates in total or social continence vary, in a period of 6 to 24 months, between 68 and 89%.[5][6]