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TELA Bio Announces Publication of 12-Month Results from the BRAVO Study with Continued Positive Outcomes Through 24 months
12-month follow-up data in 75 patients treated with OviTex® Reinforced Tissue Matrix (RTM) for ventral hernia repair demonstrates an overall hernia recurrence
About this update from Tela Bio, Inc.
[{"type":"text","content":"12-month follow-up data in 75 patients treated with OviTex® Reinforced Tissue Matrix (RTM) for ventral hernia repair demonstrates an overall hernia recurrence rate of 2.7%. Final 24-month analysis shows hernia recurrence rate remains below 5%. MALVERN, Pa., Nov. 09, 2021 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on designing, developing, and marketing innovative tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today announced the publication of the 12-month analysis from the BRAVO Study in the Journal of Clinical Medicine. TELA Bio's prospective, single arm, multicenter, post market BRAVO study was designed to evaluate the clinical performance of OviTex 1S with permanent polymer for primary or recurrent ventral hernias. A total of 75 patients were evaluated at 12 months, with only two (2.7%) patients demonstrating hernia recurrence adjacent to the original repair, leaving the primary hernia repair and OviTex intact. The 12-month analysis also showed low surgical site occurrence and surgical site infection rates. Twenty-four-month follow-up has been completed with overall hernia recurrence rates remaining below 5%. Final analysis is underway, and the 24-month BRAVO study results will be presented in a future peer-reviewed publication. \"On behalf of the entire investigator team, we are pleased to see the 12-month clinical data of the BRAVO study in publication. These 12-month results are quite encouraging and appear to be staying steady in our 24-month assessments. These results are all the more promising as our hernia recurrence rates are low and 79% of our BRAVO patient population at 12 months presented with one or more comorbidities known to increase risk of complications in hernia repair,\" said principal investigator, Dr. George DeNoto III, MD, FACS, Director of General Surgery at St. Francis Hospital in New York. \"With more and more patients expressing reservations about traditional hernia mesh to their doctors, it's critical that newer hernia reinforcement materials such as OviTex are rigorously evaluated in the clinical setting.\" In addition to primary surgical outcomes, patient quality of life was also assessed as part of the BRAVO study. The authors reported that all patient-reported assessments showed significant improv...