Commercial Evolution of Med/Surg Sealants and Adhesives

Product Development History

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 USA, 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 haemostasis products.

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. 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. An 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 (see Exhibit). 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 which 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 USA and Japan. High strength adhesives were used on approximately six million cuts, grazes and minor incisions in 2006. This usage is growing rapidly driven by greater awareness and cost effectiveness.

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

      Hemostats Sealants Adhesive
    Cardiovascular

    Yes

    Yes

    No

    Orthopaedic

    Yes

    Yes

    No

    Neurological

    Yes

    Yes

    Yes

    Gastrointestinal

    Yes

    Yes

    No

    Pediatric

    Yes

    Yes

    No

    Thoracic

    Yes

    Yes

    No

    Pulmonary

    Yes

    Yes

    No

    Skin

    Yes

    No

    Yes

    Source:  MedMarket Diligence, LLC , Report #S145, “Worldwide Surgical Sealants, Glues & Wound Closure, 2007-1011.”

    Evolution of Commercial Markets for Sealants and Adhesives

    The use of fibrin and other hemostats expanded rapidly in the 1980s in Japan driven by the strong cultural desire to avoid the need for blood transfusions in that market. In addition, regulatory barriers to launching homologous pooled plasma-derived products in Europe were not as stringent as those imposed by the US FDA in the late 1980s and 1990s. As a result the scientific literature from Asia and Europe records many novel and experimental uses for sealant and haemostasis products across all surgical disciplines from ENT to major open heart surgery.

    In addition to commercial sources of sealant products, surgical centers in all regions of the world also prepare autologous fibrin for surgical procedures in efforts to save on commercial product costs, and to avoid potential for product-borne infection. Delays to the introduction of fibrin-based products in the USA led to a pent-up unmet need, which was addressed in the 1990s by the preparation of autologous fibrin in medical centers prior to surgical operations.

    Historically, closure of surgical incisions has been achieved through an ever-evolving portfolio of suture, staple and tape products. In the early 1990s physicians involved in sports medicine were the first non-military practitioners to adopt cyanoacrylate glues to achieve immediate closure of small cuts and lacerations, and an awareness of this opportunity developed in large multinational manufacturers of sutures and staples. Joint development efforts were commenced at Davis and Geck (now U.S. Surgical), and Ethicon (subsidiary of Johnson and Johnson), and in a number of companies manufacturing cyanoacrylates which ultimately resulted in topical cyanoacrylate closure products being launched around the world during the 1990s.

    Postoperative adhesion prevention evolved as a market in the early 1990s, and expanded with the addition of new entrant products from Genzyme, Focal, and others. Lifecore and Ethicon have developed a surgical adhesion prevention product based on hyaluronic acid. Angiotech, Fidia, Fziomed and Tissuemed all have adhesion-prevention products that are CE approved in the European Union.


    Report #S145, “Surgical Sealants, Glues & Wound Closure Worldwide, 2007-2011.” For details, see link.

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