Adoption of surgical securement products by clinical category and key determinants

The potential for products in the surgical securement (sealants, glues, sutures/staples, hemostats, anti-adhesion) is driven by clinical category and the impact of the particular products, in each specialty, on a hierarchy of determinants, from the "important and enabling" to the "aesthetic and perceived benefits".  This results in a variable distribution by clinical category in the potential of each.

On a relative basis (absolute values provided in report S175), the distribution by clinical category for the adjunctive use of sealants, glues, hemostats and anti-adhesion products are illustrated below graphically, followed by the description of each category.

 

category-sealant-products

Category I: Important and Enabling
Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.

Category II: Improved Clinical Outcome
Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).

Category III: Cost-Effective and Time-Saving
Immediate reduction in surgical treatment time and follow-up treatments.

Category IV: Aesthetic and Perceived Benefits
Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.
 

See report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013."

Product development trend in surgical sealants, glues, hemostats

During the 19th century, surgeons began to experiment with materials designed to achieve hemostasis: gelatin, collagen, natural fabrics, and thrombin and fibrin materials. In the early 1980s today’s commercial products began to appear. They were rapidly adopted in Japan where bleeding is an extremely emotive issue, and also in Europe where local regulatory requirements allowed a sequential roll-out of product introductions. In the United States, early FDA concerns associated with disease transmission led to delayed launch of products derived from human sources. These regulatory delays, plus the perceived high cost of products and surgeons’ concerns regarding disease transmission risk, drove surgeons and hospitals to continue to look for alternative hemostats, sealants and glues. As a result, to this day there is a tendency for hospitals to continue to prepare autologous fibrin (from the patient’s own blood taken before surgery) and to use a number of inferior hemostasis products.

 U.S. FDA Approved Uses of Sealants, Glues, and Hemostats
 

 

Hemostats

Sealants

Adhesives

Cardiovascular

X

Orthopaedic

X

Neurological

√*

Gastrointestinal

X

Paediatric

X

Thoracic

X

Pulmonary

X

Skin

x

 

*Specific indication (few procedures per year) approved 

Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

Topical high-strength glues were first used by the military and to achieve immediate repair of sports injuries during professional sports like ice hockey, boxing and American football and basketball. These products became the subject of collaborative efforts between innovative suppliers and major suture manufacturing and marketing companies, keen to evolve their product portfolios to include next-generation closure materials.

During the 1990s, many technology-based companies began to target the huge unmet closure and sealant market and extensive literature appeared, advising practitioners on specific methodology to create the ideal autologous fibrin sealant product and on applying these products to surgical indications. In addition, a number of specialist societies were established to support and advise on the process of preparing and using hospital-derived fibrin sealants.

There were also a growing number of companies developing medical devices and equipment specifically designed to allow the preparation of autologous fibrin sealant for surgical applications. All this effort led to a number of products being approved for use in the major surgical indications (Exhibit 1-7). In 2006, sealant products were used in over three million surgical procedures. This represents up to 5 million units of commercially available fibrin sealant products, and approximately four million units of autologous fibrin prepared by hospitals. The autologous fibrin material, prepared using commercial medical devices, was used in approximately 70,000 surgical operations worldwide and represents a new market that has developed over the last five years. Similarly, the use of high-strength glues for wound closure evolved since 1992 in Europe and since 1998 in the United States and Japan. High-strength adhesives were used on approximately 6 million cuts, grazes and minor incisions in 2006. This usage is growing rapidly driven by greater awareness and cost-effectiveness.
 

Hemostasis in wound management

operating-room

Hemostatic agents 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.  

Hemostat products can be classified in six subsegments depending on their active principle: thrombin, gelatin, collagen, fibrin, synthetic materials, and other miscellaneous products that exhibit additional attributes.

The barriers for entry to the hemostasis market are reducing as many companies develop formulations of collagen and gelatin formulations for world markets. Currently, over 50 companies worldwide have products on the market for hemostatic applications.  However, a number of proprietary products and formulations still face significant regulatory hurdles associated with their development and manufacture. Most of the companies currently offering hemostat products are also actively pursuing new technologies and regulatory submissions for new products. In addition, a number of new companies are progressing additional and new technologies to market.

Sales in topical absorbable hemostats are forecast to increase at a roughly 7.5% compound annual growth rate through 2013. This growth will be fuelled by increased incidence of surgery, greater adoption of these products within the European surgical environment, and the need for improved hemostasis products during minimally invasive surgical procedures.


Excerpted from Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009."