Tag Archives: medical glue

Opportunities for med/surg sealants, glues, hemostats driven by type of clinical benefit, competition

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Advanced products for the closure, sealing, hemostasis and other endpoints for medical and surgical wounds generate varying degrees of clinical benefit based on the manner and extent to which they enable management of different wound types.  Degrees range from the acute need end of “important and enabling” to the less clinically necessary “aesthetic and perceived benefits”:

  • 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.
  • 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).
  • Cost-effective and time-saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • 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.

These benefits are clearly different on a clinical specialty-by-specialty basis.  The numbers of targeted or prospective procedures also vary considerably by specialty. As a result, wound closure and securement products have the following categorized potential use worldwide:

Source: “Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide “; Report #S190.

High Strength Medical and Surgical Glues

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See the updated, published 2012 Report #S190, “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”

Cyanoacrylate products are the main form of high-strength surgical glue that is approved for human clinical use in the worldwide market. A number of new materials are under development for internal use in particular, but these represent new chemical entities and their commercialization is likely to be delayed by regulatory requirements.  While sutures will be replaced by cyanoacrylate glues in many procedures over the next 10 years, this will only occur after some technical challenges are overcome. For example, cyanoacrylate glues used for external skin closure are approximately five times less strong than sutures, and cyanoacrylates produce cytotoxic compounds as part of the curing process when used for securing torn or excised tissue. This has delayed the development and clinical evaluation of these potentially useful materials for internal surgical procedures. However, cyanoacrylate glues are marketed actively by a number of companies for topical wound closure in accident/emergency situations and in surgical closure.

Given the current size of the global market for high strength glues (at over $700 million) and the potential for this market to expand as products overcome the challenges of strength and toxicity, a respectable number of competitors compete in this space and many are working on further developing cyanoacrylate-based and other high strength adhesives (including fibrin-based and other “bio-glues”) to not only garner greater share of the existing market but to also erode the market for sutures and other mechanical wound closure products (e.g., clips and staples).

Source: MedMarket Diligence Report #S180, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015.”

Ethicon (J&J), Covidien and B. Braun (Aesculap) hold the major positions in the market for high strength medical and surgical adhesives, but their positions are at risk, and will continue to be at risk, as long as the unmet need exists for stronger, more compatible glues.  Some of the many products on the market and in development in the area of high strength glues include SurgiSeal, DermaSeal, FloraGuard, LiquiBand, SkinLink, Histoacryl, Gluetiss, Autologous biological glue, Chemence USP Class VI adhesives, TissueGlu, Indermil, Glubran2, Glubran Tiss, GluSeal, GluSite, PeriAcryl, GluShield, Dermabond, InteguSeal, Epiglu, Surgical Tissue Sealants (STS) and others.

Report: Surgical Sealants, Glues, Wound Closure and Anti-adhesion Worldwide

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MedMarket Diligence (MMD) has published its 2010 report on the worldwide market for surgical sealants and related products in surgical and traumatic wound management.

The analysis by MMD reveals the size of the evolving opportunity for a diverse set of products in global markets. Based on extensive primary and secondary research, and leveraging MMD’s position as the leading source for the medtech industry on the subject, the report provides industry participants and hopefuls with invaluable data and insights.

The report is described below and at link. 

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments in this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.

This report is a market and technology assessment and forecast of surgical sealants, glues, hemostasis, other wound closure and anti-adhesion. The report details the current and emerging products, technologies and markets involved in wound closure and sealing using sutures and staples, tapes, hemostats, fibrin and sealant products, medical adhesives and products to prevent surgical adhesions. The report provides a worldwide historic (from 2008), current and annual forecast to 2015 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade.  The report provides specific forecasts and shares of the worldwide market by segment for the U.S., Europe (United Kingdom, German, France, Italy, BeNeLux), Latin America, Japan, Korea and Rest of World.

The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a five-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

See link for complete table of contents and list of exhibits.  The report may be ordered for immediate download from link.

Technology platforms and clinical applications overlap

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Diverse technologies have a surprising number of common threads, whether in the technologies themselves or in the clinical applications.  For this reason, manufacturers need to consider that:

1. A technology platform can be the launchpad for products in clinically diverse areas. Case in point, cell therapy, which as a fundamental scientific discipline can have uses as far afield as wound management, bone repair, treatment of myocardial ischemia and others.

2. A disease state can sometimes be targeted by many very different technologies.  Examples include that wound management can be accomplished by tissue engineering, sutures, fibrin-based surgical glues, cyanoacrylate-based surgical glues, dressings and others.

The driver behind technologies having multiple clinical applications is, of course, that companies wish to maximize their ROI.  

The driver behind single disease states being the target of multiple alternative technologies is cost — healthcare systems (in principle, anyway) seek the most competitive options for treating specific patient populations, and this driver has been gaining momentum over the past ten years due to “managed care” efforts as well as aggressive, cost-focus innovators creating technologies that displace market share with convincingly better patient outcomes compared to alternative technologies.

MedMarket Diligence publishes medical technology market reports on a wide range of clinical and technology subjects (of course, sometimes overlapping). See list.
(This post was done via the Palm Pre WebOS app Po’ster by Gabriele Nizzoli.) 

Cardiac surgery indications of high strength glues (Europe)

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High-strength surgical glue products were approved for topical closure applications in the United States in the late 1990s. Outside the United States, high-strength glues and adhesives have been approved in some countries for a number of years and have built up a track record of use in internal surgery. With time, high-strength glues will come to be used in a wider range of procedures and enable new procedures to be performed more economically with better outcomes and reduced morbidity and mortality.

We have reviewed applications and indications of commercial products and include, for the cardiac surgery example below, a list of approved indicated procedures from the European Union, as it illustrates the growing potential for these high-strength glues once they gain universal approval and adoption within the surgical community worldwide. 

  • Augmentation of aortic and vascular sutures.
  • Repair of minor epicardial lacerations without the use of sutures.
  • Hemostasis and reinforcement of anastomoses of coronary bypass and as an adhesive to optimize and secure the path of coronary bypasses on the heart.
  • Coating of perianeurysmatic tissue in ventricular aneurysm surgery.
  • Reinforcement of sutures and patch adhesion in reduction of the left ventricle.
  • As an adhesive to secure the dissection plane in acute aortic dissections.
  • As a hemostatic agent in the prevention of bleeding of proximal and distal anastomoses in acute aortic dissections.
  • As an adhesive for gluing patches for dissected aorta reinforcement.
  • As a hemostatic agent on anastomoses in aortic valve surgery, particularly in the presence of calcific or atheromatous aortas.
  • Hemostasis and reinforcement of sutures after aortic aneurysm repair.
  • In re-operations, as a hemostatic adhesive on lacerations of the ventricle caused by re-sternotomy or the presence of adhesions. 

Other specific surgery indications are provided in report S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013" for each of the following surgical fields:

  • Digestive tract endoscopy
  • Neurosurgery
  • General surgery
  • Gynecological surgery
  • Urological surgery
  • Interventional radiology and vascular neuroradiology
  • Pediatric surgery
  • Pediatric cardiac surgery
  • ENT surgery

The unmet need for non-toxic, high-strength, resorbable glues is clearly demonstrated by adoption of existing glue products outside of the United States in these multiple clinical indications. 

Spider web glue joins ranks of biologically based glues under study

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A considerable number and type of different biologically-based glues and adhesives are being studied for their potential use in human applications for wound closure. We previously addressed this in our post Sandcastle worms, mussels, burrowing frogs and gecko feet. To that list, we can now add a glycoprotein web glue from the golden orb weaving spider.

A sticky substance in spider webs may lead to the development of a new generation of biobased adhesives and glues that could replace some petroleum-based products.

See more at link.

The findings are being reported in the October 2009 issue of the ACS's Biomacromolecules. While not explicitly noted (in abstract information) for its potential use in humans, the development of any bio-based glue represents this potential.

MedMarket Diligence has published its 2009 report, "Worldwide Market for Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013." See the report's description, table of contents and complete list of exhibits at link.

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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". 

Approved neurosurgery indications for high-strength surgical glues in Europe

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High-strength glue products were approved for topical closure applications in the United States in the late 1990s. Outside the United States, high-strength glues and adhesives have been approved in some countries for a number of years and have built up a track record of use in internal surgery. With time, high-strength glues will come to be used in a wider range of procedures and enable new procedures to be performed more economically with better outcomes and reduced morbidity and mortality.

We have reviewed applications and indications of commercial products and include below a list of approved and indicated neurosurgery procedures in the European Union, as it illustrates the growing potential for these high-strength glues once they gain universal approval and adoption within the surgical community worldwide. These products have high-strength sealant and adhesive properties that will lead to their increasing adoption by clinical practitioners, starting with surgical closure and specific internal procedures for which there is no alternative. We expect that this will be followed, in the next five years, by increasing usage for gluing of tissues in vascular, neurological, spinal, orthopedic, and other procedures. We also envisage the introduction of new products and technologies that are under development to address the failings of existing first-generation high-strength glue products, to make them less toxic, more resorbable, and with higher strength.

  • As a sealant in cranial and spinal dural plastic surgery to prevent CSF fistulas.
  • As a sealant in dural plastic surgery in residual cavities following tumor removal.
  • As sealant in dural lacerations in hemilaminectomy operations.
  • Closure and filling of cranial fossae and cavities.
  • Closure of the sella turcica by the sphenoidal route.
  • Gluing of bone and osteocartilaginous fragments.

(See the complete list of procedures in Europe for high strength glues, encompassing the specific procedures in cardiac surgery, digestive tract endoscopy, general surgery, gynecological surgery, urological surgery, interventional radiology and vascular neuroradiology, pediatric surgery, and ENT surgery in Report #S175.)

From "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, 2009-2013". Report #S175.