News

Feb 11, 2016

Lyra Medical Reports Conclusive Positive Results For The First-in-Women Study Using The SRS Implant For Pelvic Organ Prolapse (POP) Treatment

Lyra’s SRS solution has been shown to deliver exceptional safety and long-term efficacy. 

Kerem-Maharal, Israel, February 11th, 2016 – Lyra Medical, a developer of safe and easy POP trans-vaginal implant procedure, announced today the completion of its First-in-Women study. This international, multi-center study was initiated in September 2014 at three medical centers in Israel and Europe. The SRS was implanted in women who suffered from symptomatic ≥2nd degree anterior vaginal and apical prolapse. All patients completed their 12-month follow-up. The mean follow-up period (as of February 2016) was 14 months (range: 12-27 months).

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

The 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 or native tissue repair procedures.

Table 1. POP-Q measurements at baseline vs. 12 months follow-up

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.

“While carrying out my first procedure I realized that the device can provide an 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,” said Dr. Zoltan Fekete, Head of Urogynecology Division, Szeged University Hospital, Szeged, Hungary

“The study results demonstrate that Lyra’s anchorless technique can restore transvaginal implants as a viable, safe and effective treatment. It addresses some of the most common and devastating complications associated with current vaginal meshes,” added Iram Levit, Lyra Medical’s CEO.

For more information about Lyra Medical’s First-in-Women study please refer to the white paper available on Lyra’s website downloads page. http://lyramed.com/topmenu/resources/downloads/

 

About Lyra Medical

Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer support implant in 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.

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