Sealants, hemostats, glues — future markets foreseen

From our past coverage of surgical sealants, glues, hemostats in our 2014 Report #S192.  (See the forthcoming June 2016 report, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022”, Report #S290.)

Fibrin and synthetic sealants offer a significant advantage over pure hemostats because they do not rely on the full complement of blood factors to produce hemostasis. Sealants provide all the components necessary to prevent bleeding and will often prevent bleeding from tissues where blood flow is under pressure and the damage is extensive.

CryoLife
Source: CryoLife

 

These products have the potential to replace sutures in some cases where speed and strength of securement are priorities for the surgical procedure.

Biologically active sealants typically contain various formulations of fibrin and/or thrombin, either of human or animal origin, which mimic or facilitate the final stages of the coagulation cascade. The most common consist of a liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use, both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components just prior to delivery to the wound. Because of the laborious preparation process, these products are not easy to use. However, manufacturers have been developing some new formulations designed to make the process more user friendly. Leaders in biologic surgical sealant space include Baxter International and Johnson & Johnson’s Ethicon Biosurgery division, but there are a number of smaller suppliers as well, in what has become an increasingly crowded field.

Compared to biologically active sealants containing fibrin and other human- or animal-derived products, synthetic sealants represent a much larger segment of the sealant market in terms of the number of competitors, variety of products, and next-generation products in development. Non-active synthetic sealants do not contain ingredients such as fibrin that actively mediate the blood clotting cascade, rather they act as mechanical hemostats, binding with or adhering to the tissues to help stop or prevent active bleeding during surgery.

Synthetic sealants represent an active category for R&D investment in large part because they offer several advantages over fibrin-based and other biologically active sealants. First and foremost, they are not derived from animal or human donor sources and thus eliminate the risks of disease transmission. Moreover, they are typically easier to use than biological products, often requiring no mixing or special storage, and many of these products have demonstrated improved sealing strength versus their biological counterparts. Synthetic products also have the potential to be more cost-effective than their biologically active counterparts. Leaders in the synthetic surgical sealants space include Baxter International Inc., CryoLife, CR Bard, and Ethicon/J&J; however, there are many up-and-coming competitors operating in this segment of the market with some interesting next-generation technologies that could gain significant traction in the years ahead. Moreover, unlike the fibrin sealants segment, where most products have more general indications for surgical hemostasis, a good number of competitors in the synthetic sealant field are focused on specific clinical applications for their products, such as cardiovascular surgery, plastic surgery, or ophthalmic surgery.

Sealants-Hemostats-Glues-companies-by-type
Source: Report #S192 (pub. 2014)

The non-active hemostats segment of the market includes a variety of scaffolds, patches, sponges, putties, powders, and matrices made of various nonactive materials that act mechanically to stop/absorb active bleeding, often in conjunction with manual compression, during surgical procedures as well as emergency use. Many of the companies active in the first two market segments discussed above also participate in this sector, including Ethicon/J&J, CR Bard, Baxter, and CryoLife, but there are also many other companies that compete in the hemostats market worldwide.


MedMarket Diligence is completing a global analysis of medical and surgical sealants, glues, and hemostats to reveal the patterns of sales, product adoption rates, and the realized/unrealized opportunities for extant stakeholders inclusive of manufacturers, buyers, and the investment arena. Publishing in June 2016, Report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022”.

 

Growth Factors in Wound Management

Growth Factors, Production and Known Effects in Wound Healing

Growth FactorProduced byCurrently Known Effects
Epidermal Growth Factor (EGF)Platelets, macrophagesStimulates fibroblasts to secrete collagenase to degrade the matrix during the remodeling phase. Stimulates keratinocyte and fibroblast proliferation. May reduce healing time when applied topically.
Transforming Growth Factor (TGF)Platelets, macrophages, lymphocytes, hepatocytesTGF-a: Mitogenic and chemotactic for keratinocytes and fibroblasts
TGFPlatelets, macrophages, lymphocytes, hepatocytesTGF-b1 and TGF-b2: Promotes angiogenesis, up-regulates collagen production and inhibits degradation, promotes chemo attraction of inflammatory cells.
TGFPlatelets, macrophages, lymphocytes, hepatocytesTGF-b3 (antagonist to TGF-b1 and b2): Has been found in high levels in fetal scarless wound healing and has promoted scarless healing in adults experimentally when TGF-b1 and TGF-b2 are suppressed.
Vascular Endothelial Growth Factor (VEGF)Endothelial cellsPromotes angiogenesis in hypoxic tissues.
Fibroblast Growth Factor (FGF)Macrophages, mast cells, T-lymphocytesPromotes angiogenesis, granulation, and epithelialization via endothelial cell, fibroblast, and keratinocyte migration, respectively.
Platelet-Derived Growth Factor (PDGF)Platelets, macrophages, and endothelial cellsAttracts macrophages and fibroblasts to zone of injury. Promotes collagen and proteoglycan synthesis.
InterleukinsMacrophages, keratinocytes, endothelial cells, lymphocytes, fibroblasts, osteoblasts, basophils, mast cellsIL-1: Proinflammatory, chemotactic for neutrophils, fibroblasts, and keratinocytes. Activates neutrophils
InterleukinsMacrophages, keratinocytes, endothelial cells, lymphocytes, fibroblasts, osteoblasts, basophils, mast cellsIL-4: Activates fibroblast differentiation. Induces collagen and proteoglycan synthesis.
InterleukinsMacrophages, keratinocytes, endothelial cells, lymphocytes, fibroblasts, osteoblasts, basophils, mast cellsIL-8: Chemotactic for neutrophils and fibroblasts.
Colony Stimulating Factors (CSF)Stromal cells, fibroblasts, endothelial cells, lymphocytesGranulocyte colony stimulating factor (G-CSF): Stimulates granulocyte proliferation.
CSFStromal cells, fibroblasts, endothelial cells, lymphocytesGranulocyte Macrophage Colony Stimulating Factor (GM-CSF): Stimulates granulocyte and macrophage proliferation.
Keratinocyte growth factorFibroblastsStimulates keratinocyte migration, differentiation, and proliferation.

Source: “Wound Management to 2024”, Report #S251

Wound healing factors; Growth in peripheral stenting; Nanomed applications

From our weekly email to blog subscribers…

Extrinsic Factors Affecting Wound Healing

From Report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

Extrinsic factors affecting wound healing include:

Mechanical stress
Debris
Temperature
Desiccation and maceration
Infection
Chemical stress
Medications
Other factors

Mechanical stress factors include pressure, shear, and friction. Pressure can result from immobility, such as experienced by a bed- or chair-bound patient, or local pressures generated by a cast or poorly fitting shoe on a diabetic foot. When pressure is applied to an area for sufficient time and duration, blood flow to the area is compromised and healing cannot take place. Shear forces may occlude blood vessels, and disrupt or damage granulation tissue. Friction wears away newly formed epithelium or granulation tissue and may return the wound to the inflammatory phase.

Debris, such as necrotic tissue or foreign material, must be removed from the wound site in order to allow the wound to progress from the inflammatory stage to the proliferative stage of healing. Necrotic debris includes eschar and slough. The removal of necrotic tissue is called debridement and may be accomplished by mechanical, chemical, autolytic, or surgical means. Foreign material may include sutures, dressing residues, fibers shed by dressings, and foreign material which were introduced during the wounding process, such as dirt or glass.

Temperature controls the rate of chemical and enzymatic processes occurring within the wound and the metabolism of cells and tissue engaged in the repair process. Frequent dressing changes or wound cleansing with room temperature solutions may reduce wound temperature, often requiring several hours for recovery to physiological levels. Thus, wound dressings that promote a “cooling” effect, while they may help to decrease pain, may not support wound repair.

Desiccation of the wound surface removes the physiological fluids that support wound healing activity. Dry wounds are more painful, itchy, and produce scab material in an attempt to reduce fluid loss. Cell proliferation, leukocyte activity, wound contraction, and revascularization are all reduced in a dry environment. Epithelialization is drastically slowed in the presence of scab tissue that forces epithelial cells to burrow rather than freely migrate over granulation tissue. Advanced wound dressings provide protection against desiccation.

Maceration resulting from prolonged exposure to moisture may occur from incontinence, sweat accumulation, or excess exudates. Maceration can lead to enlargement of the wound, increased susceptibility to mechanical forces, and infection. Advanced wound products are designed to remove sources of moisture, manage wound exudates, and protect skin at the edges of the wound from exposure to exudates, incontinence, or perspiration.

Infection at the wound site will ensure that the healing process remains in the inflammatory phase. Pathogenic microbes in the wound compete with macrophages and fibroblasts for limited resources and may cause further necrosis in the wound bed. Serious wound infection can lead to sepsis and death. While all ulcers are considered contaminated, the diagnosis of infection is made when the wound culture demonstrates bacterial counts in excess of 105 microorganisms per gram of tissue. The clinical signs of wound infection are erythema, heat, local swelling, and pain.

Chemical stress is often applied to the wound through the use of antiseptics and cleansing agents. Routine, prolonged use of iodine, peroxide, chlorhexidine, alcohol, and acetic acid has been shown to damage cells and tissue involved in wound repair. Their use is now primarily limited to those wounds and circumstances when infection risk is high. The use of such products is rapidly discontinued in favor of using less cytotoxic agents, such as saline and nonionic surfactants.

Medication may have significant effects on the phases of wound healing. Anti-inflammatory drugs such as steroids and non-steroidal anti-inflammatory drugs may reduce the inflammatory response necessary to prepare the wound bed for granulation. Chemotherapeutic agents affect the function of normal cells as well as their target tumor tissue; their effects include reduction in the inflammatory response, suppression of protein synthesis, and inhibition of cell reproduction. Immunosuppressive drugs reduce WBC counts, reducing inflammatory activities and increasing the risk of wound infection.

Other extrinsic factors that may affect wound healing include alcohol abuse, smoking, and radiation therapy. Alcohol abuse and smoking interfere with body’s defense system, and side effects from radiation treatments include specific disruptions to the immune system, including suppression of leukocyte production that increases the risk of infection in ulcers. Radiation for treatment of cancer causes secondary complications to the skin and underlying tissue. Early signs of radiation side effects include acute inflammation, exudation, and scabbing. Later signs, which may appear four to six months after radiation, include woody, fibrous, and edematous skin. Advanced radiated skin appearances can include avascular tissue and ulcerations in the circumscribed area of the original radiation. The radiated wound may not become evident until as long as 10-20 years after the end of therapy.

Source: “Wound Management to 2024”, Report #S251.


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Source: “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, Report #V201.


Selected Therapeutic and Diagnostic Applications of Nanotechnology in Medicine

Below are selected applications for neuromedical technologies in development or on the market currently.

Drug Delivery
Chemotherapy drug delivery
Magnetic nanoparticles attached to cancer cells
Nanoparticles carrying drugs to arterial wall plaques
Therapeutic magnetic carriers (TMMC) [guided using magnetic resonance navigation, or MRN]

Drugs and Therapies
Diabetes
Combatting antimicrobial resistance
Alzheimer’s Disease
Infectious Disease
Arthritis

Tissue, cell and genetic engineering involving nanomedical tools
Nanomedical tools in gene therapy for inherited diseases
Artificial kidney
ACL replacements
Ophthalmology
Implanted nanodevices for alleviation of pain

Biomaterials 

Nanomedicine and Personalized Treatments

Source: Report #T650, “Global Nanomedical Technologies, Markets and Opportunities, 2016-2021”. Report #T650.

Medtech is Dead. Long Live Medtech.

The old Chinese saying, “May you live in interesting times”, is often used as a curse (and likely originated as such), since interesting is oft synonymous with challenging, uncertain, stressful or otherwise difficult. Insult or blessing, we are entering interesting times.

The coming era of development in medical technology may be the most interesting in history. Let’s get to it.

Consider the near term:

Cost pressures, demands for improved outcomes, and need for better access to healthcare have been rising to the fore as forces overhauling markets for medical technologies.

Chronic disease has always represented a major cost challenge, given the expense of ongoing care, but as cost and quality become more demanding, while prevalence of type 2 diabetes, obesity, and associated co-morbidities increase (and compounded by higher prevalence of type 2 in an increasingly older population), driven by persistent sedentary lifestyles, diet, and other health choices, it becomes clear that chronic disease will command much attention, representing real opportunities in medtech.

Never before have so many technologies, alone or in combination, been poised to change the nature of intervention:

  • bioabsorbable, bioactive, & biocompatible devices
  • drug-device hybrids
  • surgical innovations: sutureless surgery, natural orfice surgery, intraoperative imaging and intraoperative pathology assessment, energy-based technologies;
  • information-intensive device, drug, and biotech product development
  • information-intensive medical devices
  • genetically-influenced drug development

In the medium term (next 5-10 years):

  • Type 1 diabetes gradually becomes less burdensome, with fewer complications, and improved quality of life for patients.
  • Type 2 diabetes continues to plague Western markets in particular, despite advances in diagnosis, treatment, and monitoring due to challenges in patient compliance.
  • Cancer five year survival rates will dramatically increase for many cancers. The number of hits on Google searches for “cure AND cancer” will reflect this.
  • Multifaceted approaches available for treatment of traumatic brain injury and spinal cord injury – encompassing exoskeletons to help retrain/rehabilitate and increase functional mobility, nerve grafting, cell/tissue therapy, and others.
  • Organ/device hybrids will proliferate and become viable alternatives to transplant, or bridge-to-transplant, for pulmonary assist, kidney, liver, heart, pancreas and other organ.
  • The use of stem cells for therapeutics is a radically different type of medicine, and while stem cells can be powerfully therapeutic, their use has also shown the potential to cause new cancer, graft-versus-host disease, organ damage, infection, and other direct and indirect complications. Nonetheless, the excitement around stem and other pluripotent cells creates a climate not far removed from the wild west – the potential of such open territory being up for grabs has drawn hordes of activity, not all in the best interests of patients or shareholders. The stem cell industry and others will continue to press the FDA to approve more therapies, with the pressure easing up only after a scarcity of patient deaths, complications, or just lackluster results.

Beyond 10 years, many things might happen, but which one actually happens (or the degree of its success) will be dictated by timing.

Will the big success in diabetes as we approach 2030 be cell-based — as in autogeneic pancreatic cells induced from stem cells — or will the state of the art at that time still be the “pump/meter closed loop artificial pancreas” (expected to be the case well before 2030?

Will tissue engineering allow us to preempt death?

The potential for us to preempt an enormous amount of disease is already before us, yet we studiously avoid it. At what point do we take advantage of this?

Consider what will be the case beyond 2026.

Research gaps will have narrowed drastically. The gap between basic science and clinical application will be very small. Our medical diagnostics will be extremely richly detailed, near-instantaneous, and widely accessible (e.g., there will be variants or embodiments of IBM Watson and similar intelligent diagnostic systems), which will of course optimize the potential for therapeutics. But the impact on research will be dramatic, because we will be able to much more rapidly and efficiently learn from an obvious integration of routine clinical data and research data via meta-analysis-esque (for lack of a less clumsy term) capacity to derive data from disparate local and remote systems.

Our nearly complete knowledge of the full spectrum of pathogenic factors (from environmental to genetic) and their correlation with specific patient populations will have pierced the veil that has concealed the etiologies of a large number of diseases, opening the door wide to the development of therapies.

We will understand, predict, and manage the development of genetic disease.

All political denial to the side, some of the most significant threats to our health in the future will ensue from our relentless campaign to ravage the planet’s resources – air, water, food – driven by overpopulation and happily capitalized upon by what we are seeing is a growing horde of lethal, many well evolved but otherwise persistent pathogens (from tuberculosis, MRSA, Ebola, Marburg, and many others as yet unidentified), already made more threatening due to antibiotic resistance we have knowingly facilitated.

However, fear not, my 2.3% excise tax refugees. The future is bright for you, if you care to recognize your place in it.

But first, here’s a blunt reality: Medical devices, at least as we know them, will simply become irrelevant. Medical devices, no matter how sophisticated, are clunky mechanical tools for amelioration of symptoms for diseases about which know too little to solve with near-zero cost permanent cures (think of the vaccine, an unbelievable idea in the mind of those fearing polio) but only when drugs or other interventions are not also possible.

Let there be no doubt — medical technology will thrive. Disease is persistent. Conditions are worsening for the human population. But, more importantly, at least from the sense of an industry with a big financial stake in the situation, nature does not give up her secrets easily and there remain many obstacles to overcome (not least of which is wanton and persistent human ignorance) before we are able to utterly avoid or cheaply cure all diseases.

 

 

Cerebral thrombectomy systems

Selected Cerebral Thrombectomy Systems on the U.S. and International Markets

From the 2015 report, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”.

CompanyDeviceFeaturesVessel RangeDevice Sizes (D/L)Regulatory Status
AcandisAperioSelf-expanding nitinol stent-based device with hybrid cell design and adaptable working length1.5 to 5.5 mm3.5, 4.5, 6.0 mm / 28, 30 or 40 mmCE Marked
BALTCatch+ Mini/, Catch+, Catch+ Maxi, Catch+ MegaSelf-expanding 16-wire nitinol baskets with tapering cell size design, closed distal tip and 3 distal-1 proximal radiopaque markers2.0 to 7.0 mm3.0, 4.0, 6.0, 9.0 mm / 15, 20, 30, 55 mmCE Marked
Codman /DePuyRevive SESelf-expanding nitinol basket with hybrid cell design, closed distal tip, and 3 radiopaque markers1.5 to 5.5 mm2.5, 3.0, 3.5, 4.0, 5.0, 6.0 mm / 20, 30, 40 mmCE Marked, Approved in China, South Korea, and Taiwan
CovidienSolitaire FRSelf-expanding nitinol stent-based device with Parametric design (for multiple planes of clot contact to enhance capture). Features 3 or 4 distal and 1 proximal markers2.0 to 5.5 mm4.0, 6.0 mm /26, 31, 42 mmCE Marked, FDA approved
NeuraviEmbotrapSelf-expanding nitinol stent-based device with open cell design, closed distal tip, and 3 radiopaque markers. Features dilating inner channel for rapid flow restoration and integrated distal and side branch protection2.0 to 5.5 mm3.0, 4.0, 6.0 mm / 15, 20, 30, 55 mmCE Marked
PenumbraPenumbra SystemAspiration based system comprised of vacuum pump, specialty clot capture & retrieval catheters, and Separator> 3 mm3.0, 4.0, 5.0 mm / 26 mmCE Marked, FDA approved, available in Asia, Australia, and South America
PhenoxpREsetSelf-expanding nitinol stent-based tapering device with closed ring design, and stable proximal opening2.0 to 4.0 mm4.0, 6.0 mm / 30, 45 mmCE Marked
StrykerTrevo Pro, Trevo View, Trevo XPLine of self-expanding nitinol stent-based devices (standard, all radiopaque, oversized) with spiral cell design and soft, guidewire-like closed distal tip1.5 to 4.0 mm4.0, 5.0, 6.0 mm / 20, 30, 40 mmCE Marked, FDA approved

Source: MedMarket Diligence, LLC; Report #C310.

Surgical Procedures with Potential for Sealants, Glues, Hemostats

Sealants, glues, and hemostats must offer benefit to be adopted in clinical practice, or surgical procedures. Benefits can fall into a number of categories. These range from preventing serious complications from surgery (blood loss), improved patient outcomes (fewer complications, reduction in repeats), reductions in procedure time or other time- or cost-saving benefits, or improved aesthetic and perceived benefits. See these detailed below.

Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

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Source: MedMarket Diligence, LLC; Report#S192.

We have assessed surgical sealants, glues, and hemostats for their potential in general surgery, aesthetics, neurology, urological, gastroenterology, orthopedics, and cardiovascular medicine.

Untitled-2

Source: MedMarket Diligence, LLC; Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”.


See the forthcoming report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”.  (Contact us for details to acquire the 2014 report #S192 and the new report, #S290, for a combined price before S290 publishes.)

 

It’s Personal. We fail in organ donation. Help one person.

I grew up around medicine, with a surgeon father and a pediatric uncle. I studied toward a profession in medicine as well, but I was also enormously intrigued with the science, business, and future of medicine, especially the potential emerging from biotech, with genetics and molecular biology at the top of the list. It led me to research many genetic diseases, among them cystic fibrosis (I knew someone who survived this very late, into college), and polycystic kidney disease (PKD).

Sadly, I also know someone with polycystic kidney disease, and her name is M. Christina Mayo. Tina is now in urgent need of both a kidney and liver to save her life.

I do not editorialize much here (I show restraint), but the state of organ donation in this country and worldwide is rather pathetic. We fail. And we cannot afford to fail at so simple a thing.

Last week, an old college friend of Tina’s, who also happens to be a very good friend of mine, opted to be evaluated as a “live liver” donor. (The liver is a “vital” organ, like heart and kidneys, that we can’t do without — we can donate one kidney, but techniques exist now to allow a donor to donate a lobe of the liver, rather than the whole, with the donate lobe eventually growing back.)
So, Tina’s and my friend was evaluated rigorously at UC San Francisco, where the donation would be. Unfortunately, despite so many indicators looking good, there was no match.

Tina is now making an urgent appeal (see below). And in the spirit my brother (a long time blood donor who passed away, but was an organ donor), I hope you read this and pass it along to ANYONE who might be able to help her.

I have nothing to gain from this except comfort in knowing that I bothered to take a few minutes out of my life to save someone else.

If you can donate, then I am asking you to consider this.

If you cannot donate, then please post to pass it along to anyone who might be able to.

Contact me if you have any questions: patrick@mediligence.com.
Online link to kidney donation questionnaire: https://www.ucsf-kidneytransplant.org/approach/?service=recipient.kidney:recipient.prereq.1#
Tina Mayo

Top Caseload, Growth through 2020 in Peripheral Stenting

Peripheral stenting technologies encompass all vasculature but coronary. We have assessed the volume of all such peripheral stenting procedures through 2020 worldwide.

Peripheral stenting procedures include lower extremity bare metal and drug-eluting stents for treatment of symptomatic periperal artery disease (PAD) and critical limb ischemia resulting from iliac, femoropopliteal and infrapopliteal occlusive disease; stent-grafting devices used in endovascular repair of abdominal and thoracic aortic aneurysms; as well as a subset of indication-specific and multipurpose peripheral stents used in recanalization of iliofemoral and iliocaval occlusions resulting in chronic venous insufficiency.

In 2015, these peripheral stenting systems were employed in approximately 1.565 million revascularization procedures worldwide, of which the lower extremity arterial stenting accounted for over 80%, followed by abdominal aortic aneurysm (AAA) and thoracic aortic aneurysm (TAA) endovascular repairs and peripheral venous stenting.

Below is illustrated the top geographic areas by caseload for individual peripheral stenting technologies.

Screen Shot 2016-04-14 at 8.32.04 AM

Source: MedMarket Diligence, LLC, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, Report #V201.

Below is illustrated, in order, the top growth areas geographically in peripheral stenting for the period 2015 to 2020. Note that the subtotal of all peripheral stenting products for Asia-Pacific falls within this listing of the top areas of growth in peripheral stenting.

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Source: Report #V201.

Surgical Sealants, Glues, and Hemostats: Bioactive, Nonactive, Matrices/Scaffolds

Drawn from: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

Sealants and glues are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, where leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

Surgical sealants, glues, and hemostats can be divided into several different categories based on their primary components and/or their intended use:

  • Products containing biologically active agents (e.g., Baxter Tisseel, Bristol-Myers Squibb Recothrom)
  • Products made from natural and synthetic (nonactive) components (e.g., Baxter CoSeal, Cohera Sylys)
  • Nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats (e.g., Beekin Biomedical NuStat, Equimedical Equitamp)
RevMedX XStat

Drawn from: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

Wound management regional growth (“rest of north america”)

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From Report S251 (see global analysis and the above detail for Americas (with detail for U.S., Rest of North America and Latin America), Europe (United Kingdom, Germany, France, Spain, Italy, and Rest of Europe), Asia/Pacific (Japan, Korea, and Rest of Asia/Pacific) and Rest of World.

Do you wish to see excerpts from “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets”?