Tela Bio launches post-clinical OviTex ventral hernia repair study

Tela Bio said today it initiated a post-market clinical study of its OviTex reinforced bioscaffold designed for soft tissue repair, enrolling the 1st patient at La Jolla, Calif.’s Scripps Clinic. The Ovitex reinforced bioscaffolds are designed for hernia repair or abdominal wall reconstructions, Tela Bio said. The scaffolds are designed with either permanent polymer or resorbable polymers, and are a mix of biologic and synthetic materials. “We are committed to providing surgeons with the advanced soft tissue repair materials they need, and that means we must continue to innovate and tailor OviTex products based on real-world experience. Surgeon feedback on OviTex performance and surgical handling has been positive so far, and we are excited to initiate a formal clinical data collection program that will support future efforts to refine surgical mesh design and develop new clinical protocols for hernia repair,” Tela Bio chief medical officer Dr. Maarten Persenaire said in a press release. In the Bravo study, Malvern, Penn.-based company will explore the use of the OviTex in 100 ventral hernia patients, monitoring the incidence of early post-operative surgical site occurrences, wound-related events and other complications within 3 months of surgery. Study researchers will follow up at 90 days, 12 months and 24-months, recording the incidence of true hernia recurrence, surgical site occurrences and other complications occurring more than 3 months post-surger...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Regenerative Medicine Tela Bio Source Type: news