Tag Archives: haemostasis

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

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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)

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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".

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DuraSeal(TM) Spine Sealant Receives FDA Approval

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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

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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

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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

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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

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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.

Wound closure: clinical application of alternative technologies

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Products used in surgical closure and securement include multiple types, from sutures, staples and tapes to fibrin sealants, fibrin glues, high-strength glues (e.g., cyanoacrylates, others), hemostasis and others. Clinicians managing surgical or traumatic wounds choose the appropriate product or product combination based on wound type, location, patient status and other considerations.

From the manufacturer’s standpoint, considering the market opportunity for a specific closure or securement technology is driven by effectively understanding the spectrum of clinical decisions that may involve that particular technology.

Sutures, staples and tapes provide wound closure that in certain applications are an effective solution to the wound type.  Wounds with minimal bleeding or that can be closed with resorbable sutures or that are amenable to the use of staples/clips to be removed later represent a defined target market.  However, more aggressive bleeds, a need for more rapid closure, a need to provide more effective sealing (e.g., stopping lung airleaks, sealing of the dura mater, tight closure in bowel resection, others), desire to minimize scarring and other wound demands may call for more effective hemostasis, closure and sealing than is provided by sutures or staples alone.  Fibrin, thrombin, collagen, cyanoacrylates, bio-based glues and other sealants, hemostats and glues/adhesives offer the clinician a growing arsenal of options that can be used alone or in tandem (e.g., sealants applied on suture lines) to provide more effective wound closure and accelerate the wound healing process.

Accordingly, examining the market potential for these products requires consideration of the range of alternative products and their use, alone or adjunctively.  That said, manufacturers should guard against the impulse to consider the market for any one type of closure/securement technology (e.g., hemostasis alone) without an analysis of the full range of competing or complementary technologies. 

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

New Surgical Techniques Drive Market Opportunity for Advanced Surgical Closure and Securement

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In cardiovascular and spine surgery, multi-billion dollar markets were created from entirely new procedures between 1980 and 2000, with subsequent segmentation in later years particularly as new minimally invasive procedures were developed towards the end of the 20th century. In the cardiovascular arena, the development of new procedures for angioplasty and bypasses in the late 1980s led to these procedures being performed in increasing numbers. This increase was driven by lowered risk associated with the new procedures, new product availability, and surgeon capability coupled with substantial changes in demographics caused by aging, lifestyle and economics. For example, it is estimated that approximately 20% of the over 80-year-old population suffers from some form of coronary heart disease in the United States, and the development of angioplasty procedures created a new preferable (to open heart surgery) treatment for this population.

Whereas in the United States there were 50,000 open heart surgery treatments in 1980, towards the end of the twentieth century there were 150,000 open heart bypass operations per year. There are approximately 375,000 cardiac vascular reconstruction procedures per year. In cost terms, each angioplasty in the United States costs approximately $8,000 and bypass operations cost approximately $25,000. Surgical closure and securement products are routinely used in these procedures, and new techniques like this cardiovascular example, with associated new technologies, are likely to arise in the next decade to create new market opportunities. 

During this same time frame, spine surgery has also seen tremendous growth, spurred by the combined catalyst of new technology development and an increasingly active and growing senior population.  Until the 1980s spinal surgery focused on multi-level segmental fusion procedures to fuse together several vertebrae to decrease the chance of failure at the bone metal interface. Fixation methods using Harrington hook and rod systems, Luque rods, and wires were used to achieve fusion. These procedures are notable by their invasive nature; they are associated with significant trauma and require substantial rehabilitation care for successful outcome. They were therefore initially used only in extreme cases of congenital deformity and cases of extreme trauma and pain.  In the mid- to late 1980s, a number of manufacturers developed bone screws for use in combination with these hooks and rods, which improved the achievement of stability without requiring multi-level fusion, and the emergence of threaded fusion cages in the mid-1990s added to the surgeon’s treatment options, with resultant increase in fusion success rates. The market for these products grew from tens of millions in 1980 to a $2.4 billion world-wide market in 2000. Use of adjunctive products for surgical closure and securement have already gained foothold in these procedures, which continue to grow.

Less invasive approaches to spine surgery and concomitant technology development have expanded the patient population for spine fusion procedures.   Simultaneously, a persistent demand has existed among a high caseload of patients with spine trauma and disease seeking solutions that diminish or eliminate pain, and yield lasting high quality outcomes including spine flexibility, strength and the opportunity for a more active lifestyle.  These include systems for dynamic stabilization, interspinous process spacers, artificial discs and other products.  The performance of procedures involving these products, while improving broadening the applicable caseload and improving the clinical outcomes of patients, will no less demand the use of advanced surgical closure and securement products to facilitate procedures, reduce complications and optimize results.  Fibrin sealants and glues, high strength glues and hemostasis products have established their current and future places in these fields.

Cardiovascular and spine surgery are two among many surgical fields continuing to grow, driven by patient demand and facilitated by technologies that improve outcomes.  Bariatrics, gynecologics, orthopedics, gastrointestinal and other surgeries are witnessing similar increases in procedure volume.   

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

Surgical securement (sealants, glues, hemostasis, etc.) applicable caseload in cardiovascular disease

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Cardiovascular disease is the leading cause of mortality in the United States with heart disease affecting 13 million people. Approximately 10% of these patients are estimated to be candidates who, as part of their primary treatment are also candidates for the most advanced technologies in surgical securement. Current uses of surgical securement technologies in cardiovascular disease are focused on coronary heart disease, myocardial infarction, end-stage congestive heart failure, dysfunctional heart valves, and peripheral vascular disease.

cardio-securement

Source: MedMarket Diligence, LLC; Report #S175.

 

Cardiovascular disease is a major (and growing) public health problem in developed countries, representing a major outlay of health care expenditures. It is the highest cause of death in the United States. Major multinational companies have targeted segments within this market and have promoted innovative solutions to both invasive and minimally invasive treatment of these disease states. These companies have also invested heavily in new procedures such as radiofrequency and transmyocardial laser revascularization, and biventricular pacing devices. In the future, adjunctive closure and securement products offer the potential to treat cardiovascular disease with products that aid the tissue repair process, encouraging faster recovery of surgical procedure site and donor sites.

The increasingly aging population, together with unhealthy dietary habits and a sedentary existence, are contributing to an expanded cardiovascular disease pool. The success of measures to prevent mortality from other diseases also increases this effect. In addition, rising gross domestic product (GDP) is driving increasing surgical procedure uptake in developing countries. Therefore, a huge opportunity exists for new sealant, hemostasis and closure solutions in cardiovascular surgery once new procedure-driven technical hurdles are overcome.

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