The US Food and Drug Administration (FDA) has issued 510(k) clearance for Resivant Medical’s high-viscosity tissue adhesive products, Cutiva Topical Skin Adhesive and Cutiva PLUS Skin Closure System.
This marks a significant development in tissue adhesive and wound closure technology.
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Cutiva Topical Skin Adhesive and Cutiva PLUS Skin Closure System combine the strength of super glue with the benefits of crosslinked silicone rubber.
The result is a high-viscosity adhesive that provides a strong bond, flexibility, and durability, improving both patient safety and comfort.
Resivant’s adhesive technology is dispensed via a new, single-handed applicator, designed for ease of use.
The adhesive forms a protective microbial barrier and its high viscosity ensures precise application without running, which is crucial for maintaining control during medical procedures.
The Cutiva PLUS system, which includes a surgical mesh and the adhesive, is designed for easy removal, minimising skin damage and is versatile across various surgical fields.
The mesh gives more strength instead of sutures, and it would be placed on the skin and covered with adhesive. This creates a soft, flexible, strong, strengthened barrier that will better protect the surgical site while it heals.
Resivant Medical CEO Darren Obrigkeit said: “The Cutiva platform signifies a fundamental breakthrough in cyanoacrylate adhesive technology for surgical incision and traumatic laceration closure.
“Cutiva adhesive’s unique chemistry maintains a clean incision site without the need for additional dressings and is formulated to significantly reduce the level of exposure to skin irritants.”
