MALVERN, Pa., May 19, 2021 (GLOBE NEWSWIRE) -- TELA Bio, Inc. ("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 launched the company's second post-market study, BRAVO II, to evaluate the clinical performance of OviTex® Reinforced Tissue Matrices in the robotic repair of ventral hernias. The first patient was enrolled at St. Lukes's Hospital in Overland Park, Kansas.
"We continue our commitment to developing and providing surgeons with advanced soft tissue repair materials," said Antony Koblish, President and CEO of TELA Bio. "With the continued success of our original BRAVO study and the ongoing evolution in robotic procedures for more complex ventral hernia repair, we are excited to demonstrate the efficacy and durability of the expanded OviTex portfolio in robotic hernia repair through our BRAVO II study. This study will include the addition of OviTex LPR, which has been designed specifically for optimal robot compatibility."
The company expects to enroll up to 100 subjects in the BRAVO II study at up to seven US-based sites, with patient follow-up at 90 days, 12 months, and 24 months. Study researchers will primarily monitor the incidence of early postoperative surgical site occurrences, wound-related events, and other complications within three months of surgery. Secondarily, researchers will monitor the incidence of true hernia recurrence, surgical site occurrences, and other complications occurring after three months post-surgery. Patient reported outcomes will be evaluated and recorded using quality of life and pain assessments.
"The use of reinforced tissue matrix allows surgeons to offer patients a strong and safe robotic natural hernia repair while decreasing the amount of permanent mesh that is placed in the abdomen," said Geoffrey Slayden, MD, of Saint Luke's Surgical Specialists in Overland Park, Kansas. "This technology allows us to maximize the advantages of both the permanent and remodeling aspects of the mesh."
To learn more about Core, LPR, and 1S, the OviTex Reinforced Tissue Matrix configurations that will be used in the BRAVO II study, visit telabio.com/ovitex.
