Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints.
Boston Scientific said it presented the full results from the trial yesterday at the annual scientific symposium of the American Urogynecologic Society.
The Marlborough, Mass.-based company said it enrolled a total 281 patients in the trial at 21 sites looking to compare efficacy and adverse events for non-inferiority of the Solyx system versus the gold-standard transobturator mid-urethral sling procedure.
The study was part of a post-market surveillance trial required by the FDA to be performed by all manufacturers of mesh products, Boston Scientific said. The company touted it as the first of three such studies it will complete, with remaining data expected to be released next year.
“This trial exemplifies our rigorous commitment to patient safety and our drive to positively impact the lives of the 31 million women with pelvic floor disorders. Our journey doesn’t stop there. We have invested in 16 additional pelvic floor studies to continue building the body of clinical evidence for our women’s health products, including mesh sling systems,” Boston Scientific medsurg prez David Pierce said in a press release.
The primary endpoint in the trial was treatment success defined by a composite of objective measure and any subjective self-reported improvement in stress urinary incontinence using the Patient Global Impression of Improvement at three years. Secondary endpoints included adverse events and indication of reoperation or retreatment.
Results indicated that the group treated with the SIS was deemed non-inferior to the TMUS group in composite treatment success with both intention-to-treat and per protocol analysis. Treatment success rate was 90.4% in the SIS group, versus 88.9% in the TMUS group. Rates of procedure or device-related serious adverse events at three years amongst SIS groups were non-inferior to the TMUS group, Boston Scientific said.
“These findings provide a high degree of evidence supporting the safety and effectiveness of the Solyx SIS System, as compared to transobturator mid-urethral sling (TMUS) procedures, and reinforce the use of a minimally invasive procedure for SUI. The results have the potential to impact millions of women with SUI by offering confirmation about the Solyx SIS System as a viable, first-line surgical treatment option for these patients,” study principal investigator Dr. Amanda White of the University of Texas Dell Medical School said in a prepared statement.
Last month, Boston Scientific said it launched its LithoVue Empower retrieval deployment device designed to be used with the LithoVue single-use digital flexible ureteroscope during ureteroscopic kidney stone retrieval procedures.