Tela Bio and its partner Aroa Biosurgery said yesterday that it won FDA 510(k) clearance for large-size OviTex reinforced bioscaffolds intended for soft tissue repair. The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Malvern, Penn.-based Tela Bio said. With […]
aroabiosurgery
Tela Bio, Aroa Biosurgery win CE Mark for OviTex bioscaffolds
Tela Bio said today that its partner Aroa Biosurgery won CE Mark approval in the European Union for its OviTex Reinforced BioScaffold, which Tela Bio will commercially launch in the region. Malvern, Penn.-based Tela Bio said that is has offered the OviTex RBS for ventral hernia repairs and abdominal wall reconstruction procedures in the US since July […]