New Study Shows Promise For Women Needing Mesh-Augmented Pelvic Organ Prolapse (POP) Repair
Imalux® Corporation, manufacturer of the Niris® Imaging System announces that the Niris 1300e has been successfully used to help physicians evaluate women for their suitability and response to mesh-augmented pelvic organ prolapse (POP) repair. The Imalux Niris 1300e Imaging System was used by researchers at North Shore Long Island Jewish Health System. They were able to image previously placed mesh located in the vaginal epithelium, and were able to measure the thickness of the epithelial tissue. These studies have generated valuable information relative to the success of the vaginal mesh placement procedures. Both studies were presented at the recent American Urogynecologic Society Annual Meeting.
Earlier this year, the FDA issued a series of safety communications and requirements to manufacturers of vaginal mesh to do 3-year follow-up studies on patients with vaginal mesh implants. Imalux believes that physicians using the Niris 1300e to image implanted mesh is a valuable tool to assist those mesh manufacturers during their post-market studies. Other imaging technologies, such as X-rays, CT scans, MRI's, and Ultrasound are not able to reach the resolution necessary to monitor the vaginal epithelium. Niris is FDA cleared, carries the CE Mark and is being used by leading hospitals and physicians in the USA and Europe.
In addition, Imalux believes the Niris 1300e is not only a valuable preoperative and postoperative screening tool for mesh-augmented repair candidates and recipients, but also for the entire market of postmenopausal women interested in the monitoring of hormonal treatment. The combination of noninvasiveness, ease of use, and the measurement tools of the Niris 1300e, are expected to make Niris 1300e the new imaging standard for mesh related documentation and epithelial diseases.
About Imalux® and the Niris® Imaging System
Imalux Corporation, based in Cleveland, Ohio, is a leader in the development and commercialization of site of care imaging systems utilizing harmless, near-infrared light. The Imalux technology platform, sold under the Niris® registered trademark, is based on our proprietary and patented application of Optical Coherence Tomography (OCT) to provide real-time, high resolution, cross sectional imaging of tissue microstructures. Niris is a tool to aid in the diagnosis of a variety of diseases, early detection of abnormalities, guidance of biopsy and surgery, and post-treatment surveillance in a multitude of clinical applications.