522 Post-Market Clinical Studies
Boston Scientific has completed the first of three 522 post-market clinical studies as requested by the Food and Drug Administration (FDA) Safety Notifications related to transvaginal mesh. The two ongoing studies have completed enrollment with the remaining data expected in 2019.
For more information, visit the U.S. National Institute of Health’s registry and results database of publicly and privately supported clinical studies, www.clinicaltrials.gov.
Additional Clinical Research
Boston Scientific actively partners with leading researchers in two large-scale clinical projects.
Pelvic Floor Disorders Registry (PFDR) – In support with the American Urogynecological Society (AUGS) and other industry partners, Boston Scientific is part of a national patient registry to evaluate the effectiveness, quality of life and safety associated with native tissue repair and mesh repair.
SUPeR study – Boston Scientific has contributed funding to a randomized, blinded study to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse. The SUPeR study is conducted by the Pelvic Floor Disorders Network (PFDN), a multi-center network of the National Institute of Child Health and Development (NICHD).