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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 ‘Fibrin and Other Sealants’ and the ‘Hemostats’ categories. However, at upwards of $600 per use, fibrin sealants are rather too expensive to use as hemostats. There are over 40 active companies market and/or developing hemostat products and many of them have multiple types of hemostats based on the constituent active ingredients. Below is illustrated the number of active hemostat companies based on the product types they are pursuing or selling.
Source: MedMarket Diligence, LLC, Report #S190.
The market for surgical closure and securement (sealants, glues, sutures, staples, tapes, hemostasis, anti-adhesion) has entered a phase in which major driving forces are the introduction of new procedures and techniques by the surgical profession, the development by the medical device industry of new wound closure devices and biomaterials, and the growing willingness of surgical specialists to use these devices in appropriate circumstances. There is now a continuum between simple closure using sutures and the use of specially designed devices and delivery systems with new bioresorbable securement materials either as supplements to conventional closure methodology or as stand-alone replacements.
Overall industry spending in the health care system has a major impact on this segment. Consolidation in healthcare buying organizations (particularly in the United States) creates a pressure for cost-effectiveness arguments and supporting clinical efficacy data, and may also limit pricing potential, often when the overall cost in a category appears to be growing uncontrollably. The shift to outpatient and community-based treatment sites and practices affects the way that products are designed, marketed and distributed. In the securement segment, hospital administrators are involved in purchasing more routine and generic surgical securement and closure products, with surgeons selecting more advanced and new technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theatre time and costs.