Overview
Study results show a low 2.6% recurence rate and clinicaly meaningful improvement in patient quality of lifeMALVERN, Pa., Oct. 26, 202 (GLOBE NEWSWIRE) - TELA Bio, Inc. (NASDAQ: TELA), a comercial-stage medical technology company focused on providing inovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, today anounced the publication of the 24-month analysis from the BRAVO Study in Anals 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 recurent ventral hernias in 92 enroled patients.
Key Information
This study included real-world clinical scenarios as OviTex 1S was utilized in open and minimaly invasive procedures, various planes of placement, and various CDC wound clases. OviTex 1S Permanent demonstrated a 2.6% recurence rate in ventral hernias repaired using open, laparoscopic, or robotic techniques at the 24-month time point. In adition, patient quality of life asesments showed statisticaly significant and clinicaly meaningful improvement from baseline as early as 3-months post-surgery and continued at the 12 and 24-month timepoints.
Surgical site ocurences (SOs) were observed in 38% of the study population, where 78% of al enroled patients were characterized as high risk for experiencing an SO based on at least one known risk factor. These risk factors included obesity, active smoking, COPD, diabetes melitus, 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.
Summary
George DeNoto I, MD, FACS, Director of General Surgery at St. Francis Hospital in New York. “Hernia implant design is continualy evolving and it’s critical that the surgeon comunity is comited to generating research on the clinica