The SRS–II multicenter clinical study completed recruitment of 50 patients according to study plan. Patient’s follow up is planned to three years.
Binyamina, Israel, July, 18th , 2017 – Lyra Medical Ltd. a medical device company and a developer of the anchorless trans-vaginal Self-Retaining Support (SRS) Implant, today announces the completion of recruitment in the SRS II clinical study.
The SRS–II clinical study is a multi-center (3 sites in Israel), prospective, non-randomized, single-arm, interventional clinical investigation designed to demonstrate the safety and performance of the SRS device. Study initiation was on March, 2016 enrollment was completed according to plan. The study completion is expected to be on July 2020 when all 50 patients will complete 3 years post procedure follow-up. Study population were women diagnosed with symptomatic anterior POP-Q grade 2 and above (point Ba ≥ -1).
Lyra Medical’s implant is a revolutionary surgical treatment for women suffering from advanced anterior vaginal wall prolapse with or without apical prolapse. The Self-Retaining Support (SRS) technology eliminates the need for complex anchoring techniques delivering a safe and long-term treatment solution.
“Today’s announcement marks another important step in the development of the SRS Implant. We are looking forward to the outcome of the trial expected on Q3 2020. Earlier study indicate the SRS Implant exhibits a safe and efficacy profile compared to other solution. Moreover the fact that recruitment was completed as expected indicate the good user acceptability profile of the SRS Implant. We believe that the SRS Implant has the potential to become a true “next generation” transvaginal option and a great player in the pelvic organ prolapse surgeries.” said Iram Levit, Lyra Medical’s CEO.
About Lyra Medical
Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer organ support implant for women suffering from pelvic organ prolapse (POP).
The company’s Self-Retaining Support (SRS) technology is presently being applied in the flagship Lyra system for anterior vaginal wall, Apex and uterine prolapse. The support platform may be applicable in other pelvic organ disorder conditions, such as rectocele and urinary incontinence, as well as other clinical areas. In all these areas, there is an acute need for therapeutic solutions that deliver exceptional safety and long-term efficacy.