Tag Archives: dermabond

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

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

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.

Sutureless Vascular Anastomosis and Other Applications of Sealants and Glues

(Note: This was posted initially in August 2011. The data in the table is drawn from the 2012 updated, published report #S190.)

In light of the recent development in which Stanford researchers invented a method for a sutureless attachment of blood vessels (i.e., vascular anastomosis) using a surgical glue (Dermabond), it is worth highlighting that the applications of surgical sealants and glues in medical/surgical applications are remarkably numerous, with a potential already begun to be realized in reshaping many medical and surgical procedures.

Below is an excerpt of the clinical applications by major field for surgical sealants and glues (drawn from Report #S190):

Surgical FieldApplications
CNS surgery:* Adhesive agent in CNS tissue surgery. CNS tissue cannot be sutured. Fibrin glue is almost equivalent to microsurgical suture. Fibrin glue works as a sealant but not a nerve barrier.
* Repair of dural defects.
* Others
Eye surgery:* Conjunctival closure in strabismus.
* Wound closure in glaucoma.
* Lower blepharoplasties (for lower eyelids).
* Others
ENT surgery:* Myringoplasty in large persistent tympanic membrane perforation.
* Repair of laryngotracheal separation with cricoidectomy.
* Narrowing of nasal fossa in atrophic rhinitis.
* Others
Oral and dental surgery:* Local hemostatic measures in patients with bleeding disorders and patients on anticoagulants.
* Sealing of oro-antral fistula.
* Others
Head and neck:* Parotidectomy closure.
* Axillary dissection in carcinoma of the breast. Reduces adhesion, bleeding and serous drainage with earlier drain.
* Prevention of mastectomy seroma.
* Others
Cardiovascular thoracic surgery:* Reduced postoperative bleeding and intrapericardial adhesion.
* In cardiothoracic surgery using fibrin glue significantly reduced postoperative bleeding.
* Others
Chest surgery:* Sealing of prolonged air leak after thoracotomy in lung cancer.
* Bronchopleural fistula.
* Percutaneous lung biopsy.
* Others
Vascular surgery:* Microvascular anastomosis: Suture may induce vascular narrowing, foreign body reaction, intravascular thrombosis but are less common in those with fibrin glue application.
* Others
Gastrointestinal surgery:* Gastrointestinal sutureless anastomosis-stent.
* Esophagus perforation.
* Esophago-jejunal anastomosis.
* Recurrent tracheo-esophageal fistula.
* Upper gastrointestinal tract fistula: Endoscopic obliteration.
* Cholecysto-jejunostomy (sutureless) using absorbable intraluminal stent.
* Others
Liver surgery:* Liver resection in benign and malignant diseases.
* Others
Uro/Gynecological system:* Colpofixation in stress urinary incontinent.
* Intractable transplant-ureteral fistula.
* Transvaginal colpo-urethropexy.
* Others
Gynecological surgery:* Recto-vaginal and ano-rectal fistula.
* Anastomosis of the fallopian tube in animals.
* Others
Bone & orthopedic surgery:* Joint replacement.
* Brachial plexus injury repair.
* Others
Plastic surgery:* Face lift procedure. Fibrin glue reduces major hematomas and ecchymoses.
* Musculo facial plastic surgery, dorsal hand burns, infected skin graft.
* Decrease wound contraction in skin graft.
* Others

Note: “Others” are detailed in Report #S190.

Source: MedMarket Diligence, LLC; Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2012-2017.”

Secrets of Bio Glues

Researchers at the University of Akron have revealed the evolutionary strength of spider web glue. Published in the May 17, 2010, issue of Nature Communications, the research revealed that the effectiveness and strength of the spider web glue ensues from the highly entangled, cross-linked polymers in each droplet of the glue, which enables the adhesive force to be transmitted throughout the glue.

UA researcher Vasav Sahni notes:

[The] stickiness of the glue droplets depends on the speed at which they are stretched.

Subsequently, the glue droplets can hold on to fast-flying insects when they initially impact webs and retain trapped insects for a time period long enough for them to be subdued by the spider.

“This finding should significantly benefit the development of synthetic adhesives for biomedical, orthopedics and wound-healing applications. The understanding of how spiders use this unique glue will allow scientists to develop reversible adhesives that work in the presence of water,” says Dhinojwala.

As we have often highlighted in the past ("Sea life and other sources of glue to mend people" link or "Bio Glues" link), a wide range of biological sources have been identified and are under evaluation (or adaptation) as medical and surgical glues due to their evolutionarily-designed strength, biocompatibility and other inherent advantages.

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

Technology platforms and clinical applications overlap

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.) 

Sealants, Glues and Advanced Securement in the Americas

Taken together, the Americas represent some 60% of the global market, led by the United States with more than 50%.  The main medical markets in Latin America are Brazil and Mexico, followed by Argentina.

non-usa-securement1Unlike the wealthier U.S. market where private insurance dominates the market, 75% of the population in Brazil is covered by the state-run Unified Health System (although only 42% of the country’s healthcare spending is in the public sector).  Accordingly, securement markets in Brazil are dominated by use of conventional, low-cost closures (sutures, staples, tapes) dominate the market, while more expensive novel closures (sealants and glues) have relatively modest market shares. The same is true of Argentina, which is still recovering from a severe economic depression in the 1990s. Mexico, the eighth biggest trading market in the world, operates a health care system under which 60%–70% of the population are covered by public insurance schemes. In terms of expenditure on medical products, Mexico occupies a position between that of developed and developing economies, and this is reflected in the shares of the wound closure market represented by premium-priced and commodity product groups.

Nonetheless, growth of conventional closures like sutures, staples and tapes is relatively stagnant in the non-USA Americas compared to growth of advanced securement market.

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

High strength medical glues and adhesives

Originally from MedMarket Diligence Report #S175. See the 2012 Report #S190, “Worldwide Surgical Sealants, Glues and Wound Closure, 2010-2017.” See also “High-Strength Adhesives versus Sutures/Staples in Wound Closure” from the 2012 Report #S190.

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.

Sutures will be replaced by cyanoacrylate glues in many procedures over the next 10 years but these adhesives do not represent the ideal alternative to suturing. 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.

 Companies Commercializing Cyanoacrylate-based High-Strength Medical Adhesives

cyanoacrylates

Source: MedMarket Diligence. See 2012 updated report #S190.

Active programs are under development in three categories of new high-strength adhesive closure and securement products. The first of these comprises the application of medical grade cyanoacrylates to internal procedures for many new surgical indications and the development of procedure-enabling devices for the delicate and precise application of these strong adhesives will lead to strong market segment growth. The second category of new products will arise from improvements and new indications for existing biomaterial adhesives. The third category of new products will arise over the next decade and will include new polymer adhesives based on new chemistries.

Growth in high strength medical adhesives is in excess of 20% annually due to recent regulatory approvals and will be sustained, though at more modest rates, over the next decade. It will be fueled by increased incidence of surgery, greater adoption of these cyanoacrylate and newer adhesive products for internal surgical applications, and the need for improved, fast-acting and easy-to-use products for use in minimally invasive procedures. In addition, it is becoming recognized that these products have a role to play in reducing infection and improving cosmesis of surgical wounds to the surface of the skin and this will also drive the value of this attractive market segment.


See the 2012 Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

Sample of one: surgery, electronic patient records, other insights from an ER visit

Insights from a trip to the ER:

  • img_0004For even a minor laceration ("only" four stitches), cyanoacrylate-based surgical glues (e.g., Dermabond) will be ineffective unless the site is entirely free of blood.  While cyanoacrylates have an advantage in adhesive strength, their toxicity for internal applications, plus this need for bloodless field, seriously limits their potential.
     
  • The involvement of the commonly used blood thinner, Plavix, has a very distinct impact on what would otherwise be minor bleeding.  Minor epistaxis, for example, can require an ER or urgent care visit if the patient is on Plavix.
     
  • Digital imaging (x-ray) has a very direct, positive impact on patient care.  The ability to obtain a computerized image rapidly that can be readily transmitted from Radiology to the patient record accessible by the ER doc shortens the gap between the x-ray order and the doc’s ability to make a clinical decision based on the results. This improves time and improves the efficiency of the visit as well as the usefulness of the patient record.  Imaging difference in quality compared to film is probably relatively insignificant.
     
  • Healthcare, despite many advances, remains fairly inefficient, even in the best facilities.  The need for coordination across multiple departments (even between triage and ER units), with patient records, and the lack of point-of-care imaging causes delays in patient care, tying up beds and delaying the clinical decision-making of ER docs.  Electronic patient records that are accessible across different points of care (doc offices, ER, etc) would speed care and reduce complications (e.g., patient record always reflecting the most current presciptions and their dosage).
     
  • Peer review of new technology is a necessary check and balance against unproven developments, but still delays the adoption of potentially important new options available to the clinician.  Manufacturers have a significant hurdle in penetrating the mainstream, routine use of new technologies, but can minimize this in having a highly focused effort on delivering technology with value that clinicians can readily appreciate for its ability to improve clnical outcome, save time or otherwise improve patient care and the ability with which clinicians can deliver it.
     
  • Mission Hospital in Mission Viejo, CA, has an excellent level of service
     

I appreciate any feedback others have on heealthcare experience, especially as it may be driven or influenced by technology.