General Surgery Sealant
Problem: The need for effective, tissue compatible surgical sealants for wound closure and the reinforcement of suture and staple-line junctions is widely acknowledged. Unfortunately, existing sealants lack sufficient tissue adherence and internal cohesive strength to withstand fluid leaks after certain procedures and maintain closure after surgery as the tissue heals naturally underneath. As such, out of a US surgical sealant market potential of 3.5M procedures, caseload penetration is currently less than 15%. In common, leakage-prone procedures such as vascular anastomosis and dura reconstruction, leakage rates remain above 10%, resulting in life-threatening surgical complications.
Solution: LifeSeal SurgicalTM sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.
Competition: Three types of sealant products are currently marketed: fibrin, synthetic (generally based on polyethylene glycol), and protein-gluteraldehyde. Both fibrin and synthetic sealants lack sufficient adhesive strength for many applications while the safety of the protein-gluteraldehyde sealant is a widely known problem. As a result of these limitations, surgical sealant use is currently restricted to vascular sealing, low level hemostasis, and tissue fixation, with no product able to fully satisfy surgeon needs. This explains the tremendous gap between the market potential for surgical sealant use and the current levels of sealant usage.
* The product is not approved for marketing