TELA Bio’s Restella Reconstructive BioScaffolds Receives FDA’s 510(k) Clearance for Reconstructive Surgery

Shots:

• The US FDA granted 510(k) clearance to Restella reconstructive bioscaffolds as it reinforced soft tissue in patients requiring soft tissue repair or reinforced during plastic or reconstructive procedures
• TELA Bio technology is based on interwoven polymer with a layer of biologic tissue in lockstitch pattern Additionally, TELA Bio has a strong clinical portfolio including OviTex Reinforced BioScaffolds for hernia repair and abdominal wall reconstructions and is commercialized in the US
• Restella reconstructive bioscaffold is a device intended for one-time use only and is highly permeable with controlled stretch to support surgical techniques. TELA Bio plans to form resorbable and permanent polymer versions of Restella reconstructive bioscaffolds in different sizes & shapes

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