NAPLES, Fla., Feb. 22, 2013 /PRNewswire/ — Falls River Group LLC announces they have been engaged by Imalux Corporation, manufacturer of the FDA cleared, Niris 1300e imaging system, to pursue strategic relationships for the company in order to increase the widespread use of the system.
A newly developed application for this amazing technology is in the imaging of vaginal mesh used in the repair of pelvic organ prolapse, as reported in the December 14, 2012 issue of OCT News. Earlier this year, the FDA issued a series of safety communications and requirements to manufacturers of vaginal mesh to do three-year follow-up studies on patients with vaginal mesh implants. Imalux believes that by utilizing the Niris 1300e, physicians and manufacturers now have access to a valuable tool for the visualization of implanted vaginal mesh as part of the mandated post-market studies.
The company also believes the Niris technology will ultimately aid physicians in determining the need for hormonal replacement in the treatment of peri and post-menopausal women by using measurements of the vaginal epithelium. Niris 1300e has been shown to be more accurate, less invasive, and generate more consistent results compared to other imaging technologies such as ultrasound in applications where Niris can be used to evaluate the rate of thinning of the vaginal wall as a determinant for hormone replacement therapy.
