TELA Bio, Inc., a commercial-stage medical technology company focused on providing technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, announced the publication of a 24-month analysis from a 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 synthetic mesh is often used for ventral hernia repair, however the significant, long-term foreign body footprint may lead to chronic inflammation, infection, and persistent pain. OviTex Reinforced Tissue Matrix was designed to offer surgeons and patients an alternative to permanent synthetic mesh that minimizes the use of permanent synthetic materials to provide a more natural repair.
“We are very proud to share the full, final results of our BRAVO study,” stated Antony Koblish, President and CEO of TELA Bio. “Since the founding of TELA Bio we have been committed to validating the performance of OviTex from the bench-top to the OR. This commitment continues with our ongoing BRAVO II study which will evaluate the use of OviTex in robot-assisted ventral and inguinal hernia repairs.”