The US Food and Drug Administration (FDA) has granted 510(k) approval to Chemence Medical’s redesigned Exofin fusion skin closure system.
The US Food and Drug Administration (FDA) has granted 510(k) approval to Chemence Medical’s redesigned Exofin fusion skin closure system.
Exofin fusion offers a self-adhering, flexible mesh strip and a rapidly curing 2-octyl cyanoacrylate topical adhesive, which covers and seals incisions while also creating an immediate microbial barrier to protect against infections.
The latest product was updated by reshaping the mesh strip and moving the initiator. The changes were made after noting common complaints found in the FDA MAUDE database.
Chemence Medical president Jeff Roberson said: “We consulted with healthcare professionals across many different disciplines and found that the current wound closure devices all presented similar challenges, which were an increase in cellulitis as well as blistering of the skin, or skin shear.
“We feel that our newly designed product has successfully eliminated the factors that could lead to poor patient outcomes while still delivering on the great attributes that a product like this can offer.”
The updated Exofin fusion has a mesh with curved ends. This new shape reduces the area for potential damage due to stress by 67% when compared to the original rectangular shape.
Along with the design change, the chemical used to cure the adhesive was relocated from the mesh itself to within the adhesive design. This reduces patient exposure to the initiator chemical by more than 60%.
Exofin fusion previously had traditional sizes of 22cm and 60cm. Now, it is also available in a new 30cm size, which covers orthopaedic incisions where 22cm does not suffice.
