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. Lyra’s technology mimics the physiologic pubocervical fascia and restores pelvic organs to their anatomical and functional location. This anchorless technique restores transvaginal implants as a viable, safe and effective treatment that far surpasses current mesh kits, sacrocolpopexy and native-tissue repair procedures.
• Eliminates mesh complications
• Frame retains mesh tension and prevents folding, eliminating the risk of erosion
• Frame prevents mesh contraction and over-time tension, eliminating failures, pain and dyspareunia
• No blind insertion of trocars, eliminating the risk of bleeding or organ perforation
Easy to Use
• Identically follows current surgical techniques while eliminating the need for complicated fixation steps
• Simplifies the procedure
• Short operation time
• Short learning curve
70 patients were recruited and treated in international multi-center studies. As of August 2019, available data includes a follow-up period of 27.7 (range 11.4-41) months.
Ongoing Clinical Trials
Lyra’s first-in-women trial was initiated in September 2014, at three Medical
Centers in Israel and Europe followed by an additional study initiated in
March 2016 in three study centers in Israel. Both studies include patients
suffering from symptomatic ≥2 degree anterior vaginal with/without apical
prolapse. The vast majority of patients (90%) were stages 3 and 4. As
of August 2019, 27 (39%) patients completed their 36-month follow-up,
33 (47%) completed their 24 month follow-up and 10 (14%) patients
completed their 12 month follow-up. Only one patient refused vaginal
examination after the 12 month follow-up visit, but was still followedup
for subjective results. This patient reported no AEs, no symptoms
and no other changes from her previous (12 mo.) follow-up visit.
- * Values given as # of patients (%), mean cm (range)
** Last follow-up visit for each patient [N=70]. As of December 2018: 19 patients (27%) completed their
36 months FU; 24 patients (34%) completed their 24 months FU; 26 patients (37%) completed their 12
months FU; all the patients completed their 6 months FU;
All procedures have been carried out uneventfully. No mesh erosions or chronic pelvic pain were observed in any patient until now. One patient experienced a frame erosion which was solved by partial removal of the implant bridge under local anesthesia without any further consequences. This was the only patient implanted with a large implant.
To date, objective anatomical, subjective and safety results are similar in both studies. One patient (1.4%) had a symptomatic recurrence of her apical prolapse (C=0), two patients (2.8%) had an asymptomatic recurrence of their apical prolapse, representing 91.4% anatomical success. Results suggest that the safety profile and clinical outcome of an anchorless implant is potentially better than that reported for other trans-vaginal surgical meshes, sacrocolpopexy or native tissue repair procedures. For further details refer to these studies in the white paper available on Lyra Medical’s website (www.lyramedical.com), under the resources tab.
SRS technology provides the ultimate implant for the treatment of anterior wall vaginal prolapse. The ease of use and the impressive anatomical and subjective outcomes are far superior to any other mesh implants ever used.I am confident that SRS-based solutions will revolutionize the treatment of prolapse, the same way that TVT did to treating incontinence. I have no doubt that SRS will become the next gold standard for reconstructive pelvic surgery.
Prof. Mauro Cervigni, Professor Urogynecology, Dept. Urology “La Sapienza”
Univ.-Polo Pontino, ICOT-Latina, Italy
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. At the follow-up visits, I was very satisfied when patients expressed their gratitude on the outcome and from the short and painless recovery period. Overall, the anatomical and subjective results are excellent.
Dr. Anna Padoa, Assaf Harofeh Medical Center, İsrail, Editör: “The Overactive Pelvic Floor”
While carrying out my first procedure I realized that the device can providean excellent solution for pelvic organ prolapse. 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. I hope that more of my patients will get the chance to benefit from the Lyra SRS solution in the future.
Dr. Zoltán Fekete Head of Urogynecology Division,
Szeged University Hospital, Szeged, Hungary When you examine a happy patient with optimal anatomy 24 months after SRS implantation, you realize that this unique design provides perfect results even in the most advanced prolapse cases. The Lyra SRS is optimal: short procedure, painless recovery and superior subjective and anatomical results. It is hard to use any other implant after you see the results of
the Lyra SRS.
Dr. Gil Levy, Director Devision of Female Pelvic
Medicine, University Hospital, Assuta Ashdod, Israel
The Lyra SRS implant is very friendly and easy to use. With an overall operating time of 12 minutes from startto- end, it’s the fastest procedure that I have ever done. So far the anatomical results are very promising.