Chemence Medical said today it won FDA clearance for its Exofin Fusion skin closure system designed for medium to large wounds.
The Exofin Fusion skin closure system features a self-adhering mesh strip, mesh anchors and a fast-curing 2-octyl cyanoacrylate topical adhesive to close and seal large incisions and form a microbial barrier to protect from infections, the company said.
Alpharetta, Ga.-based Chemence said the Exofin Fusion is designed for multiple uses, but is most applicable for orthopedic procedures including total hip and knee replacements, cardiovascular procedures, plastic surgery, spinal procedures and obstetrics for C-section closures.
“Our new skin closure system can really improve the operating room experience for doctors and patients when closing larger wounds. The self-adhering mesh and anchor system allows for easy application and enables surgeons to close incisions faster than sutures, while the adhesive cures in less than a minute. Meanwhile, the waterproof microbial barrier reduces the patient’s likelihood of readmission due to infection, allows them to shower immediately after surgery, and the innovative anchor system improves comfort during removal. Exofin Fusion brings the features doctors and patients love about topical wound closure adhesives to a whole new array of procedures. Chemence Medical is excited to introduce the next step in topical skin adhesives,” prez Jeff Roberson said in a press release.
Last February, Chemence said it won FDA 510(k) for its Exofin topical skin adhesive designed for wound closure.