Acera Surgical has announced the receipt of a new US Food and Drug Administration (FDA) 510(k) clearance for its Restrata platform, which is now approved for soft tissue reinforcement applications.
This clearance extends the clinical use of Restrata, previously authorised for wound healing, to include support for soft tissues, particularly in procedures where tissue weakness is present or where closures are at risk of dehiscence.
The approval encompasses the use of both the Restrata Sheet and Restrata Meshed products.
The Restrata Sheet is designed for use in patients requiring soft-tissue repair, featuring a non-biologic electrospun fibre matrix that facilitates granulation tissue activation in persistent wounds while maintaining flexibility.
On the other hand, the Restrata Meshed product can be expanded to twice its initial coverage area while preserving strength and integrity, making it suitable for suturing or stapling during soft-tissue repair procedures.
Acera Surgical CEO Mike Finegan said: “This clearance marks a significant step forward, not only for our clinical partners but also for the broader commercial trajectory of the Restrata platform.
“By addressing both soft tissue healing and reinforcement, we’re delivering a truly versatile solution that meets a diverse set of surgical needs with one synthetic, resorbable technology.”
Engineered in the US, Restrata utilises electrospinning technology to create a bioresorbable synthetic polymer matrix that offers structural support to soft tissues. Once implanted, it is fully resorbed within three to four weeks while providing reinforcement during crucial healing phases when complications such as dehiscence are most likely.
Acera Surgical co-founder and chief scientific officer Matthew MacEwan said: “Surgical site dehiscence and wound breakdown represent a significant challenge, particularly in orthopaedic and reconstructive surgery.
“Restrata addresses this unmet clinical need by providing early mechanical support to protect closures when they’re most vulnerable, then resorbing as native tissue strength returns.”
Based in St. Louis, Missouri, Acera Surgical specialises in bioscience and electrospun technology innovation for regenerative medicine. The company focuses on developing and commercialising technologies like Restrata that mimic human extracellular structures to aid soft tissue healing across various surgical settings.
