Improving Repair of Female Congenital and Reproductive Anomalies

Project Summary The overall goal of this SBIR proposal is to develop a novel vaginal stent for use in pediatric and adult populations. There are many girls and women born with congenital gynecologic abnormalities requiring surgical reconstruction of their vaginal cavities. There are also women who have very shortened or scarred vaginas after pelvic surgery or radiation treatment for cancer. Vaginal stents can be used after neo-vagina creation to prevent scarring and re-stenosis. There are no currently available vaginal stents that meet the anatomic needs of pediatric and adolescent girls or women who are post treatment for gynecologic cancers. As such, there is a high rate of post-surgical complications such as vaginal tissue scaring and vaginal stenosis. We propose to create new vaginal stents with improved fit, ease of use, unique deployment and retrieval mechanisms, and enhanced comfort for a pediatric population and for those women with shortened vaginas. Biotex has completed a SBIR Phase I project where we created novel stents and deployment mechanisms, completed benchtop performance testing, and evaluated multiple design configurations during in vivo animal studies with promising results. The objectives of our Phase II proposal is to build on this work by creating updated custom prototypes based on prior pre-clinical work and physician input, test designs in normal volunteer subjects, lock down a final design and complete required validations for FDA 510(k) filing, and test the stents in the intended population of adolescents undergoing vaginal reconstructive surgery, and women after radiation treatment for gynecologic cancers. We believe this new vaginal stent will reduce post-surgical morbidity, early discontinuation of stent use postoperatively, reduce health care costs, and improve clinical outcomes for girls and women across North America.Project Narrative The goal of this Phase II SBIR project is to continue development of a novel vaginal stent specifically designed to address the anatomic needs of the pediatric, adolescent, and gynecologic cancer patients. This newly designed vaginal stent will reduce early discontinuation of stent use postoperatively and improve post-surgical outcomes with regards to restenosis for girls who have undergone pelvic surgery and for women who have undergone pelvic surgery or radiation due to gynecologic cancer treatment. We will build on work done in Phase I to arrive a a market ready device the conclusion of this Phase II project.