TELA Bio, Inc., 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, 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.
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. 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 Journal of Clinical Medicine.
This retrospective study examined the two-year recurrence rate of the robotic-assisted reinforced biologic augmented repair (ReBAR) of inguinal hernias from June 2018 to April 2022. All repairs employed the standard robotic transabdominal preperitoneal (rTAPP) approach combined with the novel ReBAR technique, which consists of suture closure of the defect followed by a biologic mesh reinforcement. After two years, only three recurrences were identified from the 157 inguinal hernias repaired using the ReBAR technique - a rate of 1.9%, and only two SSOs were identified in this cohort.
“We are proud to share these positive clinical results for both our BRAVO patient population and those who underwent a ReBAR repair. We believe this research demonstrates that we’re succeeding in our mission to provide an effective portfolio of tissue reinforcement solutions while minimizing the permanent synthetic polymer footprint,” stated Antony Koblish, President and CEO of TELA Bio. "Today’s patients are eager for a repair solution that is more natural and contains less permanent foreign bodies. These results show that OviTex not only meets these criteria but also contributes to increasing patient quality of life.”