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TELA Bio Announces Publication of 24-Month BRAVO Study Results Demonstrating Benefits of OviTex® Reinforced Tissue Matrix in Hernia Repair
Study results show a low 2.6% recurrence rate and clinically meaningful improvement in patient quality of life MALVERN, Pa., Oct. 26, 2022 (GLOBE NEWSWIRE) --
About this update from Tela Bio, Inc.
[{"type":"text","content":"Study results show a low 2.6% recurrence rate and clinically meaningful improvement in patient quality of life\nMALVERN, Pa., Oct. 26, 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 the publication of the 24-month analysis from the BRAVO Study in Annals of Medicine and Surgery. TELA 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. This study included real-world clinical scenarios as OviTex 1S was utilized in open and minimally invasive procedures, various planes of placement, and various CDC wound classes. 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. In addition, patient quality of life assessments showed statistically significant and clinically meaningful improvement from baseline as early as 3-months post-surgery and continued at the 12 and 24-month timepoints. 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). “I want to thank the entire investigator team for their diligence in completing this important study,” said principal investigator, Dr. George DeNoto III, MD, FACS, Director of General Surgery at St. Francis Hospital in New York. “Hernia implant design is continually evolving and it’s critical that the surgeon community is committed to generating research on the clinical safety and efficacy of newer implants. Our results provide evidence that OviTex 1S Permanent in ventral hernia repair results in a low rate of recurrence and improved quality of life for patients over a two-year period.” Over 400,000 ventral hernia repairs are performed in the U.S. annually, most of which require the use of a reinforcement device. Permanent synt...