Tela Bio touted data this week for its OviTex reinforced bioscaffold used for hernia repair and abdominal wall reconstruction.
The device combines biologic material and polymer, allowing for free movement of fluid and cells through the mesh. Tela Bio’s chief medical officer is slated to present initial feedback from surgeons using the device since it won FDA 510(k) clearance in June last year.
Surgeons observed 134 patients treated with OviTex and provided feedback for 128 patients after 108 days of follow-up, on average. The company reported that the surgeons did not observe any device failures or hernia recurrences.
“OviTex RBSs have now been successfully used in a wide range of hernia repair procedures,” Dr. Maarten Persenaire said in prepared remarks. “Surgeons are noting that OviTex RBSs are easy to handle, trim, suture, and tack in all surgical approaches, and conform well to contours of surgical sites. We are also encouraged by surgeon reports of reduced volume and duration of drainage post-operatively. This gives us confidence for our prospective multi-center ventral hernia Bravo study which started enrollment this April.”
In a separate presentation, chief technology officer Skott Greenhalgh and hernia surgeon Dr. Stephen Ferzoco touted data from a preclinical study assessing the permeability of various hernia repair materials, including OviTex RBSs.
The study showed that the company’s mesh exhibited permeability, which stood in contrast to market-leading biologic materials and coated synthetic meshes, according to Tela Bio.
“Little attention has been paid to the permeability of hernia repair materials and the role permeability plays in their clinical performance,” Greenhalgh said. “We believe it is important that OviTex RBSs exhibit permeability, as this may reduce the incidence of post-operative complications, including seromas. Furthermore, permeable implants could enhance tissue integration and remodeling through free movement of fluid and cells, which are critical to long-term durability of the repair.”