Surgical sealants are wax or gel-like substances used alone or with sutures to completely seal internal and external incisions after surgery. They are particularly important following lung or spinal operations, where air and cerebrospinal fluid can leak through the suture holes, causing numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.
Several formulations of fibrinogen and thrombin have been developed. The most common formulation is the liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components and delivery to the wound. Because of the laborious preparation, these liquid products are not easy to use.
Over two dozen companies are active in the development and/or marketing of surgical sealants. Product formulations include the following
- polyethylene glycol (PEG), oxydized alginate, gelatin and other hydrogels
- diisocyanated prepolymer
- proprietary cross-linking formulations
- synthetic matrices
- naturally-derived bioglues
The market potential of surgical sealants is dictated in one part on the penetration of (limited) sealant-only procedures and adjunctive use of sealants with sutures, staples and clips. Predictable hurdles already the focus of development include challenges to create sealants that:
- provide high-tensile strength adhesion
- enable tight-sealing that will prevent air/fluid leaks
- are free from direct or byproduct toxicity or other negative side effects
- are biodegradable
- allow ease of use
- provide hemostatic as well as sealant benefits
- are cost effective
For this reason, sutures, staples and clips — however low-tech they may be — have staying power in clinical practice and the market and are therefore expected to represent a stubborn potential market for sealants to penetrate:
Source: "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017", Report #S190 (MedMarket Diligence, LLC).