Fibrin and other sealant products have been approved and used outside the United States for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many such products have been marketed in these regions for up to 20 years and have been developed for a variety of surgical uses. While in the United States these products were approved initially as hemostatic adjuncts to suturing, they are increasingly being used for sealing of tissues, yet their use beyond hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the United States.
For the vast majority of surgical procedures, sutures and staples remain the most common methods of closure, but often they are sub-optimal. They do not have inherent sealing capabilities, and therefore cannot stop air and fluid leakage (for example in lung resection) and fluid leakage at the wound site. Furthermore, friable tissues such as the liver, brain or spleen, are fragile and often cannot support sutures or staples. Therefore, other means of wound closure are required for repair of these tissues.
However, the steady pace of FDA approvals and market introductions for products with sealing capabilities illustrates the success manufacturers have had in surmounting many of the technical hurdles to these products providing strong roles in tissue sealing. These include approvals by Baxter (Tisseel), Genzyme (FocalSeal), GluStitch (GluShield), Angiotech (CoSeal, Vitagel), CryoLife (BioGlue), and Syneture/Covidien (Indermil).
Applications of Fibrin Sealants and Other Surgical Sealants
- Local hemostatic measures for both surgical and trauma cases
- Surgery in patients with bleeding disorders (e.g., hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid oozing
- Surgery in nonsuturable organs (e.g., brain, liver, lung, pancreas, thymus) or to repair unhealthy tissue (e.g., irradiated bowel or tissue of elderly patients)
- Cardiovascular, microvascular surgery and vascular grafts (e.g., aneurysm repair, coronary bypass, etc.)
- Nerve grafts
- Skin grafts, particularly plastic surgery
- Surgery of small or difficult to reach organs (e.g., tympanoplasty, ENT, eye)
- Sealing of body cavities, fistulae, pneumothorax, cranium, etc.
- Anastomosis of gastrointestinal, tract and other ductal organs
Source: MedMarket Diligence, LLC; Report #S175