Clinical Data

SRS-I

Lyra's First-in-Women trail, an international, multi-center study, was completed in February 2016 at three Medical Centers in Israel and Europe. 

Since September 2014, clinical use of the SRS implant has begun under clinical study in women who suffer from symptomatic anterior vaginal and apical POP-Q grade ≥2 prolapse.

All patients completed their 24 months follow-up and are being followed for additional 2 years.  Mean follow-up period (as of Feb. 2017) 25.8 months (range: 24-29 months).

Results thus far are excellent and conclusive. All patients had complete anatomical cure with POP-Q measurements of the treated compartments at normal values.

A sole case of frame erosion was secondary to an oversized implant and therefore can be easily prevented.

 

Results:            

Population: 20 patients who suffer from symptomatic anterior vaginal and apical POP-Q grade ≥2 prolapse
Objective: Validating the safety and performance of the SRS implant
Follow-up period (as of Feb. 2017): 25.8 months (range: 24-29 months)
Results: - On follow-up 100% of the patients had POP-Q measurements of the treated compartments at normal values.
- Participating surgeons overwhelmingly endorsed the procedure.
- A single case of minimal frame erosion was treated in an ambulatory setting.

 

SRS-II

Based on the overwhelming success of the first study, Lyra's second human multi-center trial is currently ongoing at three Medical Centers in Israel.

Study initiated in March 2016 and will recruit 50 women who suffer from symptomatic anterior vaginal and apical POP-Q grade ≥2 prolapse.

To date, all procedures have been carried out uneventfully.