Hemostats have been used for over a hundred years to prevent bleeding in the surgical situation. Primarily these products were first introduced to prevent hematomas during surgery with the aim of preventing resultant infections. During the 1980s and 1990s, the popularity of hemostats increased rapidly as surgeons tried to avoid excessive use of blood transfusions for reasons of economy and the threat of disease transmission. Products were launched during this period by many of the large medical device manufacturers, such as Johnson & Johnson, which now sells Surgicel (an oxidized regenerated cellulose hemostat), Instat (a freeze-dried collagen product), and Spongostan/Surgifoam (a freeze-dried gelatin hemostat).
For stopping bleeding, modern hemostats go far beyond simple gauze. Almost all hemostatic agents work in conjunction with or in addition to the body’s own blood clotting activity. These agents generally work by physically obstructing the outflow of blood in the wound, accelerating clotting reactions, and providing a matrix for increased platelet interactions, resulting in faster and stronger fibrin clot formation that can bind to and seal vascular injuries. However, the effective hemostatic action of these products depends heavily on the patient having a capable and intact coagulation function. This may not be the case if the patient has received, for example, a synthetic colloid fluid in the field to prevent shock, which results in hemodilution, or if the patient is hypothermic or in hypovolemic shock. If there is pre-existing coagulation deficiency, then many of these hemostats will not work. There is a need for a hemostatic agent that can function effectively in the absence of the patient’s coagulation function. One of the products that function well in these situations is the fibrinogen-based dressing. Fibrin sealants can also act as hemostatic agents, so there is in effect some overlap between the products categorized as “fibrin and other sealants” and “hemostats”. However, at upwards of $600 per use, fibrin sealants are rather too expensive to use as hemostats.
Select Characteristics of the Ideal Hemostatic Dressing
- Approved by the US FDA (in the United States) or having the EU CE Mark (in the European Union)
- Stops severe arterial and/or venous bleeding in 2 minutes or less
- No toxicity or adverse side effects
- Does not cause pain or thermal injury
- Poses no threat to medical personnel
- Ready to use, requires little to no training
- Durable and lightweight
- Flexible so as to fit complex wounds, easily removed without leaving residues behind
- Stable and functional at extremes of temperature for at least 2 weeks
- Practical and easy to use under adverse weather conditions
- Effective on junctional wounds not amenable to tourniquet
- Long shelf life, preferably at least 2 years
- Inexpensive, cost-effective
- Biodegradable and bioabsorbable
Hemostat Product Formulations
Overall, the market for hemostats is dominated by Ethicon.
Hemostat Global Market Shares
However, with a large number of clinical applications targeted by over 40 active companies globally that are marketing and developing hemostatic products, and with a lower barrier to market entry than for fibrin sealants, the market for hemostats offers a lot of opportunities for companies to position their products through features and price. Moreover, the shares of companies vary by moderate to significant amount in different countries and regions.
See updated (2014) Report #S192.