Fibrin and other med/surg sealants have broad, expanding use

Fibrin and other medical/surgical sealants have developed a broad repertoire of applications supported by their utility addressing different wound and tissue types.

Below is a sampling of 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; Report #S175

Fibrin sealants represent a revolution in local hemostatic measures for both bleeding and nonbleeding 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.

The challenges to even more widespread adoption of fibrin and other sealants are fading as formulations and delivery methods have been aggressively developed by manufacturers to meet the demand, but opportunities remain, including providing better tensile strength, ease of delivery, better cost and others.

The worldwide market for fibrin and other sealants stands at $2 billion (see link).


Purchase for download:  Report #S175, "Sealants, Glues, Wound Closure (2009) PDF" — $3,250.00
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CryoLife Announces First Clinical Use of BioFoam(R)

CryoLife Announces First Clinical Use of BioFoam(R)
(Reuters )

BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed. BioFoam received CE mark approval for …  | See original press release

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The use of BioFoam for liver resection represents a strong trend toward the expanded use of sealants and glues for internal applications, even if only used adjunctively with other closure. 

See the MedMarket Diligence report #S175 on "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013".

Posted via email from medmarket’s posterous

DuraSeal(TM) Spine Sealant Receives FDA Approval

Covidien gained FDA approval this week for its DuraSeal for the sealing of sutured dural tears, which occur in 10% of all spinal fusion procedures.  (See DuraSeal(TM) Spine Sealant Receives FDA Approval.) 

DuraSeal

DuraSeal, originally developed by Confluent Surgical, is a PEG (polyethylene glycol) solution and a trilysine amine solution, that has been shown effective in preventing intra-operative and post-operative surgical complications as a result of fluid, air and blood leaks.  In 2005, the FDA gave approval for DuraSeal in cranial procedures.  

The development of surgical sealants is moving increasingly toward internal use. Currently, most sealants are fibrin- or thrombin-derived and are effective at hemostasis, with sealing being a less significant function served due their need for greater strength in in adhesion.  Cyanacrylate-based sealants might otherwise represent a viable alternative for internal sealing, but their toxicity has kept their use to predominantly topical applications.  

Sealants like DuraSeal (HyperBranch Medical also makes a dural sealant, which has received CE Mark for Europe but is awaiting U.S. FDA approval) are making progress in demonstrating internal applications, albeit via adjunctive use (e.g., creating a seal along suture lines) rather than as stand-alone sealants.


Below is an overview of fibrin sealant and glue use and development (from MMD report #S175).

The terms “sealant” and “glue” 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 nonbleeding 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 United States 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 such products have been marketed in these regions for up to 20 years and have been developed for a variety of surgical uses. While in the United States these products were approved initially as hemostatic adjuncts to suturing, they are increasingly being used for sealing of tissues, yet their use beyond hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the United States.
For the vast majority of surgical procedures, sutures and staples remain 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.

However, the steady pace of FDA approvals and market introductions for products with sealing capabilities illustrates the success manufacturers have had in surmounting many of the technical hurdles to these products providing strong roles in tissue sealing. These include approvals by Baxter (Tisseel), Genzyme (FocalSeal), GluStitch (GluShield), Angiotech (CoSeal, Vitagel), CryoLife (BioGlue), and Syneture/Covidien (Indermil).

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

The evolution of commercial markets for surgical 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 addition, regulatory barriers to launching homologous pooled plasma-derived products in Europe were not as stringent as those imposed by the U.S. 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 hemostasis 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 United States 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/U.S. Surgical (now Covidien), and Ethicon (subsidiary of Johnson & 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.

Post-operative adhesion prevention evolved as a market in the early 1990s and expanded with the addition of new entrant products from Genzyme (including 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.

synthetic-bioloigical-sealants

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

Manufacturers of Surgical Sutures, Staples, Clips, and Other Mechanical Closure Devices

The vast majority of sutures, staples and endostaples are used following procedures involving acute surgical wounds. Typically, chronic wounds do not involve use of suture and staple products unless some degree of surgical intervention is employed to remove necrotic tissue or to create a new acute wound bed to aid healing.

Sutures comprise two component parts, the needle and the suture, and these can be found in a wide range of sizes and types, made of a range of materials, and the method of attachment of the suture to the needle can involve a variety of methods. Sutures are divided into braided and monofilament categories. Braided sutures are typically more pliable than monofilament and exhibit better knot security. Monofilament sutures are more wiry and may require a more secure knot. Their major advantage is that they cause less tissue drag, a characteristic that is especially important in cardiovascular, ophthalmic and neurological surgery. Over the last few years, some companies have developed devices (such as Abbott Vascular’s Perclose, ProGlide and Prostar suture-mediated devices) that can complete the suturing process and tie the finishing knot quickly.

Stapler devices can be seen as an evolution of suture technology. The goal of stapler products is to avoid infection, remove some of the difficulty of skillful suturing, and make total procedures quicker and easier. Staples are made of stainless steel and biomaterials and are used to join internal tissues, reconstruct or seal off organs, remove diseased tissue, occlude blood vessels, and close skin incisions. They are primarily used during surgery as internal and/or external closure devices.

Staples are available in an assortment of sizes and features; procedure-specific stapler devices have been developed to take staple clips for use in one specific procedure or for multiple uses. Internal staplers are used to approximate internal tissues and organs. The devices may be reusable or disposable. Some disposable staplers may be reloaded several times during the course of a single patient surgical procedure and then discarded.

suture-staples-clipsThe most recent internal staplers are used to perform minimally invasive surgical procedures that allow the surgeon to endoscopically secure internal wounds instead of having to operate through an open procedure. Staples can be made to dissolve, and this obviates the need for removal; these staples are ideally suited to laparoscopic surgery and delivered via procedure-specific laparoscopic instruments. However, most staples are still made of stainless steel and when used for internal stapling procedures, whether open or laparoscopic, are not removed after healing. Skin staples are removed after the incision is healed.

Perhaps the major benefit of staples is that they can be applied more rapidly than sutures and can be placed precisely without requiring the skill necessary for sutures. This also means increased safety for the patient, and patients can often be discharged more rapidly as a result of stapling procedures.

While cosmetically acceptable results are usually obtained, staplers normally are not used in highly visible areas such as the face. Here surgeons will still close by hand to minimize any scarring. In many procedures, sutures have begun to be replaced by cyanoacrylate glues, but the ideal alternative to suturing has not yet been developed; for example, cyanoacrylate glues used for external skin closure are only one-fifth as strong as sutures.


Source:  MedMarket Diligence, LLC; Report #S175.

The market for surgical sutures, staples, clips and other mechanical closure are analyzed in the global market for these and competitive/complementary products in the report, "Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013". 

Introduction of new surgical glues, sealants, anti-adhesion products to the U.S. market

new-securementMedMarket Diligence’s 2009 report #S175 is an analysis of the companies exploiting medical devices targeted at the surgical securement market to examine the products they market and the timelines associated with their approvals.

A greater awareness of regulatory approval mechanisms and requirements around the world has become apparent in this market sector, and we believe this indicates a growing trend in the medical device industry overall. In the United States, a new medical device is usually marketed after the FDA approves a pre-market application (PMA) or clears a 510(k) pre-market notification submission. Through a conscious effort by the FDA, the time required for the agency to carry out this approval has been steadily reduced and is now around 3 months for a 510(k) and 13 months for a PMA. The FDA has also worked to make the approval process less arbitrary.

Regulatory bodies in Europe and Japan also have achieved significant advances in the last 10 years to streamline their approval processes so that clear guidelines are given for approval and reimbursement categories. In addition, companies making submissions have become more aware of the need to identify the key factors for approval and to engage with the regulatory bodies early in the process to clarify the routes forward for any exceptional aspects of product development.
We also found that all medical device businesses (from small biotechnology companies to large capital conglomerates) are becoming more efficient at managing their new product pipelines, and focusing on a mixture of short-term product concepts and longer-term, more risky breakthrough opportunities.


MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

Wound closure and securement share of global medical device market

The market for surgical closure and securement 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.

Worldwide expenditure on all medical devices reached nearly $200 billion in 2008, and in the field of tissue repair and surgical securement, the total market reached $7.8 billion, underpinned by product advances reflecting our improved understanding of the underlying mechanisms of tissue repair, patient demographic pressures creating an increasing caseload of procedures, and a rapidly expanding number of new products available.

Late 2008 and early 2009 represented some of the most challenging times in the global economy for all industries.  Medical device markets fared markedly better and now remain poised for a strong rebound.  In the outlook, however, the economy is less of a determinant than the potential impacts of healthcare reform, which is moving toward legislation of some form by year-end 2009.

closure-securement-growth-rates

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

The tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are growing to be components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions.


See Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013.