MALVERN, PA — TELA Bio, Inc., a surgical reconstruction company leading the development and commercialization of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced that early outcomes from the company’s post-market BRAVO (BioScaffold Reconstruction of Abdominal wall and Ventral hernia defects with Open or laparoscopic repair) study evaluating OviTex 1S Permanent for the treatment of ventral hernias are being presented at the 2018 Abdominal Wall Reconstruction Conference taking place June 7 – 9 at the Grand Hyatt Washington in Washington, DC.
In the single-arm, prospective BRAVO study, investigators are monitoring the incidence of early postoperative surgical site occurrences (SSOs) or wound-related events occurring at the hernia repair site, complications, and recurrences, as well as conducting quality of life and satisfaction assessments. The initial data presented includes the first 24 patients who reached 90-day follow-up in the study. Seven patients experienced SSOs that were related to the type of surgical procedure performed, however, none required surgery or removal of implant, and resolved at the time of analysis. To date, no subject has experienced a recurrence. The patient and surgeon satisfaction with the hernia repair are high.
“Our first analysis of prospective data from the BRAVO study suggests that OviTex is at least as effective as other biologic or resorbable implants,” said principal investigator George DeNoto III, MD, FACS, director of general surgery at St. Francis Hospital in New York. “We look forward to continuing follow-up with patients in this important study evaluating a novel surgical implant.”
TELA Bio first commercialized OviTex RBSs in July 2016. They are a distinct class of surgical implants that integrate biologic and synthetic materials in a unique embroidered construction that allows movement of fluid and cells through the construct. Over 2,000 implantations have been completed to date in a wide range of hernia procedures using a variety of surgical techniques.
“We are committed to continuously study and evaluate our portfolio of next-generation products for soft tissue repair and help achieve improved patient care and surgical outcomes while reducing costs,” said Maarten Persenaire, MD, CMO of TELA Bio. “The initial results from our post-market study are in line with the enthusiastic and nuanced feedback we are receiving from surgeons who already have implemented the use of OviTex in hernia repair procedures across the U.S.”
Source: TELA Bio, Inc., 1 Great Valley Pkwy Ste 24, Malvern PA 19355
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