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TELA Bio Highlights Results from BRAVO and ReBAR Studies on the Benefits of OviTex® Reinforced Tissue Matrix in Hernia Repairs; Data to Be Presented at 2022 American Hernia Society (AHS) Meeting
24-Month BRAVO study results showed a 2.6% recurrence rate in diverse clinical scenarios Robotic Reinforced Biologic Augmented Repair (ReBAR) study showed a
About this update from Tela Bio, Inc.
[{"type":"text","content":"24-Month BRAVO study results showed a 2.6% recurrence rate in diverse clinical scenarios Robotic Reinforced Biologic Augmented Repair (ReBAR) study showed a 1.9% recurrence rate at two-year mark MALVERN, Pa., Aug. 04, 2022 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, today announced that two studies examining clinical outcomes with use of its OviTex Reinforced Tissue Matrix will be presented at the 2022 American Hernia Society (AHS) Meeting. The conference, taking place from September 14-16, 2022, in Charlotte, North Carolina, will highlight the outcomes of two studies that underscore the efficacy of OviTex. 24-Month results of the BRAVO Study: A prospective, multi-center study evaluating the clinical outcomes of ventral hernias treated with OviTex 1S Permanent Reinforced Tissue MatrixAHS presentation on Friday, September 16th, 10:20-10:30 a.m.ETTELA Bio's prospective, single-arm, multi-center clinical trial was designed to evaluate the clinical performance of OviTex 1S with permanent polymer embroidery for primary or recurrent ventral hernias in 92 enrolled patients. OviTex 1S Permanent demonstrated a 2.6% recurrence rate in ventral hernias repaired using open, laparoscopic, or robotic techniques at the 24-month time point. Surgical site occurrences (SSOs) were observed in 38% of the study population, where 78% of all enrolled patients were characterized as high risk for experiencing an SSO based on at least one known risk factor. These risk factors included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years). This study included diverse clinical scenarios for ventral hernias as OviTex 1S was utilized in open and minimally invasive procedures, various planes of placement, and CDC wound classes I-III. The use of OviTex 1S in BRAVO patients also resulted in clinically meaningful improvements in their quality of life and perceived health. Improvements were reported as early as 90 days after surgery and this improvement persisted over the 24 months of follow-up. These BRAVO 24-Month results follow the publication of the BRAVO 12-Month study, released in November 2021 in the Jou...