TELA Bio®, Inc., a surgical reconstruction company leading the development and commercialization of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced that data from a retrospective study evaluating the use of RBSs in abdominal wall reconstruction procedures show low recurrence and complication rates. The results were being presented at the Americas Hernia Society (AHS) International Hernia Congress 2018 held March 12-15 at the Fontainebleau Miami Beach in Florida.
OviTex RBSs integrate biologic and synthetic materials in a unique embroidered construction that allows free movement of fluid and cells through the construct. The biologic material, derived from ovine rumen, allows for functional tissue remodeling, while the polymer provides additional strength and improved handling.
Michael Sawyer, MD, FACS, general surgeon at Comanche County Memorial Hospital, conducted a retrospective chart review for a consecutive series of 14 patients undergoing AWR with OviTex RBSs used for reinforcement between June 2016 and November 2017. Recurrence rates, and rates of surgical site infection and other surgical site occurrences were analyzed as primary endpoints. Results from the study show a low recurrence rate (7.1%) and low complication rate (14.3%) at average follow up of about one year.
Dr. Sawyer reported, “AWR for complex incisional hernias is a challenging surgical task, and the repairs require reinforcement for durability and to decrease the incidence of recurrence.” He added, “Synthetic and biologically derived reinforcement materials have their own inherent strengths and weaknesses. OviTex RBSs possess properties of both, representing a new paradigm in repair reinforcement that may improve patient outcomes and warrants longer-term study.”
TELA Bio first commercialized OviTex RBSs in July 2016 and over 1,700 implantations have been completed to-date in a wide range of hernia procedures using a variety of surgical techniques. The company has initiated a post-market clinical study, BioScaffold Reconstruction of Abdominal wall and Ventral hernia defects with Open or laparoscopic repair (BRAVO).