Research & Development
TELA Bio wins US FDA's marketing clearance for large size OviTex reinforced bioScaffolds for hernia repair
11 January 2019 -

Surgical company TELA Bio Inc and Aroa Biosurgery Thursday jointly announced the receipt of the the US Food and Drug Administration's (FDA) 510(k) clearance to market OviTex RBS for hernia repair and abdominal wall reconstructions, including the most complex cases.

Following the US FDA"s marketing approval, TELA Bio will now launch the OviTex Permanent product line commercially in US from in large sizes up to 25x40 cm (1,000 cm2), which is a 150% surface area increase over currently available devices.

A distinct class of surgical mesh, OviTex RBSs are the only devices available that reinforce biologic materials with polymer fibres in a unique embroidered construction that allows for functional tissue remodelling, as well as improved strength and handling.

TELA's OviTex Reinforced BioScaffolds (RBSs) products are intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.



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