FDA Approves New Surgical Adhesive: SurgiSeal

Dermabond, watch out! Wyomissing, Pennsylvania firm Adhezion Biomedical is reporting that its highly differentiated cyanoacrylate based surgical sealant has been approved for marketing by the FDA. In addition to surgical sealant applications, the company seems to be working on incorporating its technology for other indications, such as wound management and infection prevention. But for now, surgical sealant it is.

From the product page and press release:

SurgiSeal™ is a topical skin adhesive that provides the optimal balance between strength and flexibility. SurgiSeal can replace sutures that are 5-0 or smaller in diameter for incision or laceration repair and is designed to save time during wound repair, provide a flexible, water-resistant, antimicrobial protective coating, and eliminate the need for suture removal.
Cyanoacrylate medical adhesives are designed to save time during wound closure, provide a flexible, water-resistant, microbial barrier coating, and eliminates the need for suture removal. 2-octyl cyanoacrylate formulas feature greater breaking strength and broader use in clinical applications than existing n-butyl-2-cyanoacrylates.
Dr. Danie Hoffman, a plastic and reconstructive surgeon who has been using SurgiSeal since its international launch, states, “SurgiSeal does an excellent job of sealing the wound, and its applicator provides very easy, controlled use. It will save staff time in attending to lacerations.”
Confirms Pete Molinaro, CEO of Adhezion Biomedical, “SurgiSeal’s patented OctylFlex monomer process can be used in a wide array of topical product applications, addressing skin lacerations, incisions and plastic surgery. It meets the needs of surgeons and patients seeking less disruptive, more natural healing solutions that are both durable and versatile.”

The video, illustrating the device: