Patients recruited for the study suffered from symptomatic pelvic organ prolapse (≥2 degree anterior vaginal with/without apical prolapse). The vast majority of patients (90%) suffered from advanced prolapse (stages 3 and 4).
As of August 2019, 31 patients (44%) had completed their 36-month follow-up, 33 patients (47%) had completed their 24-month follow-up, and 6 patients (9%) had completed their 12-month follow-up. The mean follow-up period as of August 2019 was 30.1 months, and the majority of the data collected (91%) was based on 2 and 3 years of follow-up.
Years of Follow-up
- A single (1.4%) frame erosion, due to oversized implant and insufficient dissection. Implant size variation has since been discontinued and training has been updated.
- Maher C, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;4
Compared with Existing Treatments
Efficacy & Safety
- As defined by the FDA - a combination of anatomical and subjective results, and the need for retreatment
- Implant/procedure related complications
- Lyra Medical Ltd. data on file
- Extracted from an executive summary report delivered by Boston Scientific as part of an FDA panel
CLINICAL TRIAL PIPELINE
Post-Market Clinical Follow-Up (PMCF)
A new comparative study is currently being designed, and will be conducted on a new research group. This study will demonstrate risk-benefit profile of the SRS Implant vs. Native Tissue Repair (NTR), in the treatment of anterior and apical pelvic organ prolapse.
Doctors and Patients Speak About SRS
Univ.-Polo Pontino, ICOT-Latina, Italy
Ziv Medical Center, Israel
University of Augsburg, Germany
Szeged University Hospital, Szeged, Hungary
Editor: “The Overactive Pelvic Floor”
University Hospital, Assuta Ashdod, Israel