The terms â€œsealantâ€ and â€œglueâ€ tend to be used interchangeably in the surgical context, but in fact there is a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.
Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and non bleeding disorders. Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for hundreds of years. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. It is used for local hemostasis and as an augmenting material during arterial bleeding. It has been applied to every organ except eyeballs. It has been shown to be very useful for local hemostasis, a valuable tool for adhesion, sealing, anastomosis, vascular and nerve grafts, and many other procedures
Fibrin and other sealant products have been approved and used outside the USA 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 products that have been on sale in these regions for up to twenty years and have been developed for a variety of surgical uses. In the USA, these products are approved mainly as hemostatic adjuncts to suturing; elsewhere they are used much more extensively as sealants and low-strength glues, as well as for their hemostatic properties. Listed below are some applications found in a recent survey of surgical procedures around the world. We believe that this represents an untapped market opportunity within the US market for these products.
More than 25 million surgical procedures are performed in the, USA each year, and proper closure of all wounds is vital to achieve efficient healing. Sutures and staples are 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.
As of today, several hemostatic agents, including fibrin and other sealants, provide hemostasis and sealant capabilities by complementing and accelerating the bodyâ€™s natural blood clotting processes. The adhesive strength of fibrin and other sealant products is often considered to be insufficient to close wet tissues on their own, and the hemostatic characteristics of these products are sometimes viewed as inadequate for actively bleeding tissues. For these reasons, these products have been considered as adjuncts for many closure applications; in the USA, the FDA has approved products as adjunctive for hemostasis and closure of surgical incisions. As examples, the FDA approved a number of surgical sealants including RapidSeal Patch introduced by Fusion Medical Technologies, the Tisseel product sold by Baxter, and Haemaseel fibrin sealant distributed by Haemacure. The RapidSeal Patch was approved for the indication of sealing air leaks in lung surgery, and Hemaseel and Tisseel were approved for cardiovascular and severe splenic injuries. We believe that there is justification for these products to be considered by surgeons as vital adjuncts for specific surgical indications where tissues are friable, where there is a risk of continued leakage of fluid or gas, and where hemostasis is important to the outcome of the procedure.
The exhibit below illustrates the major surgical applications of fibrin and other 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
As an example, in trauma, uncontrollable bleeding and complications associated with the requirement for massive blood transfusion account for the majority of deaths in patients requiring surgery for intra-abdominal hemorrhage. Approximately 15 percent of trauma patient admissions involve intra-abdominal hemorrhagic injuries. Unfortunately, high rates of failure and mortality are seen with existing surgical procedures, which are based on the use of quantities of gauze for blood absorption, and application of localized pressure to treat hemorrhagic injuries such as these. This unsophisticated technique has the further disadvantage of the need for further intervention after a few days to remove the gauze. Fibrin and other sealants offer improved success rates for these operations.
In addition to controlling bleeding during trauma surgery, cardiovascular bypass, angioplasty, cranial and spinal sealing, total knee and hip replacement procedures, pneumostasis during lung surgery, and liver and spleen surgical operations are the most immediate untapped opportunities for sealant products in the USA. Research into current practice outside the USA has revealed that fibrin and other sealants have a role in many types of surgical procedures (see report #S145).
(From “Worldwide Surgical Sealants, Glues & Wound Closure, 2007,” report #S145, published February 2007.Â Copyright 2007, MedMarket Diligence, LLC.)