Clinical Evidence

Our clinical experience is based on hundreds of procedures, and includes two international studies conducted on 70 patients diagnosed with advanced symptomatic pelvic organ prolapse. Spoiler alert – results were outstanding.

Research Group

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).

Duration

The studies were launched in September 2014 (SRS-I) and in March 2016 (SRS-II).
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.
* Clinical data was formally collected until the completion of a 3-year follow-up period

Years of Follow-up

1
2
3
4
5
6
7

20 Patients

SRS-I Study

50 Patients

SRS-II Study

Years of Follow up
1
2
3
4
5
6
7

20 Patients

SRS-I Study

Years of Follow up
1
2
3
4
5
6
7

50 Patients

SRS-II Study

SRS RESULTS

Efficacy

96%
anatomical success (Ba≤-2)
Lyra’s stringent success criteria.
100%
anatomical success (Ba≤0)
Industry standard success criteria adopted by the FDA.
98.5%
subjective success
Patients' prolapse sensation
Swipe for more
POP-Q
Pre-op
At Follow-Up
Stage 0
0
57 (81%)
Stage 1
0
10 (15%)
Stage 2
Threshold above Hymen
3(4%)
3(4%)
Stage 2
Threshold below Hymen
4(6%)
0
Stage 3
51 (73%)
0
Stage 4
12 (17%)
0

Safety

Swipe for more
Complication
SRS Implant
Other Devices2
Pain
0%
2%
Urinary Dysfunction
1.4%
9%
De-Novo SUI
2.8%
12%
Repeat Surgery
0%
11%
Mesh Erosion
0%
11.4%
Infection
0%
2%
Painful Intercourse
0%
8%
Frame Related1
1.4%
N/A
  1. 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.
  2. Maher C, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;4

Compared with Existing Treatments

Efficacy & Safety

Swipe for more
Success Rate1
Complication Rate2
Lyra Medical’s SRS Implant3
97.2%
4.2%
Other TVM Implants4
83.3%
25%
Native Tissue Repair (including SSF)4
73.8%
22%
  1. As defined by the FDA - a combination of anatomical and subjective results, and the need for retreatment
  2. Implant/procedure related complications
  3. Lyra Medical Ltd. data on file
  4. 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

Prof. Mauro Cervigni
Professor Urogynecology, Dept. Urology "La Sapienza"
Univ.-Polo Pontino, ICOT-Latina, Italy
Dr. Na’ama Marcus
Head of Urogynecology Unit,
Ziv Medical Center, Israel
Dr. Friedrich Pauli
Head of the Interdisciplinary Center of Pelvic Surgery in Gynecology,
University of Augsburg, Germany
Dr. Zoltán Fekete
Head of Urogynecology Division,
Szeged University Hospital, Szeged, Hungary
Dr. Anna Padoa
Assaf Harofeh Medical Center, Israel
Editor: “The Overactive Pelvic Floor”
Dr. Gil Levy
Director Division of Female Pelvic Medicine,
University Hospital, Assuta Ashdod, Israel
"
The SRS provides the ultimate implant for the treatment of anterior vaginal wall prolapse. The ease of use and the impressive anatomical and subjective outcomes are superior to any other mesh implant I have ever used. I am confident that SRS Implant will revolutionize the treatment of prolapse, the same way that TVT did in treating incontinence. I have no doubt that SRS will become the next gold standard for reconstructive pelvic surgery.
"
"
The Lyra SRS Implant is very friendly and easy to use. With an overall operating time of 12 minutes from start to finish, it’s the fastest procedure I have ever performed. So far the anatomical results are very promising.
"
"
The SRS Implant provides the most effective and safest treatment of anterior vaginal wall and apical/uterus prolapse. At first, I was skeptical as to the advantages of the SRS Implant, however, after using it for some time now, I have no doubt that the SRS Implant is superior to any other implant product offered on the market today. I am confident that by offering the SRS Implant to my patients, I am giving them the safest and most effective surgical treatment available
"
"
The simplicity of the Lyra SRS insertion makes it the most straightforward implant I have ever used. The anatomical and subjective results are very promising in comparison to mesh solutions I have used in the past, and the benefit to patients is huge.
"
"
My previous experience with vaginal mesh made the Lyra SRS Implant procedure easy to adopt. The surgery itself was short and the postoperative recovery was without any noticeable adverse events. During the follow-up visits, patients expressed their satisfaction with the outcome and the short and painless recovery period.
"
"
When you examine a happy patient with optimal anatomy three years after SRS implantation, you realize that this unique design provides perfect results even in the most advanced prolapse cases. The procedure is short, the recovery is painless and the subjective and anatomical results are superior, making it hard to use any other implant.
"