Hemostat Market Research Indicates Strong Growth

Source: Mediligence Blog

Sealant, Glue and Wound Closure Global Market

Profibrix - Market Summary

EU Lacks Transparency In Adverse Event Reports

The regulatory considerations for the US are often cited as so rigorous that they delay valued technologies reaching the market. However weak EU vigilance and a systemic vision for EUDAMED lacking transparency earmarks all EU individuals as easy victims for massive medical device testing and product failure.
In todays world of outsourcing of Medical Device production to manufacturing wild west territories such as India and China concerns should be creating a greater need for vigilance and freedom of public access. And yet Eudamed state:

Who can access Eudamed?

Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission and is not publicly accessible. Eudamed is currently being used by a number of Member States on a voluntary basis and will be obligatory as from May 2011.

However the public are not to be informed, it would seem reasonable for a patient or physician to have available adverse event reports (proven or not). It seems EU citizens will not have this visibility.......WHY???
Fundamentally the EU lacks transparency for both patients and physicians in terms of adverse event reports, it also lacks clearly defined regulation of notified bodies and along with this does not indicate clear packaging notification of origin of country production. A company registered anywhere in the world may not be required to specify their product is produced, packaged and sent from India, China or Timbuktu. 

All of this also begs the question of "What events happen in Mexico, Yemen and beyond?". The case for Global Harmonisation is an issue often discussed but will ultimately be driven by a disaster.

The following Belgian Document (French initially, but English follows) highlights major concerns.

Blood Banking & Blood Products Market to Reach US$36 Billion by 2015

San Jose, CA (Vocus) September 7, 2010
The global market for blood banking and blood products is exhibiting a healthy trend. New infections continue to take a toll on the population across the world, fueling the demand for blood banking and blood products. Regulatory, and healthcare bodies across the world are adopting stringent policies relating to blood safety. As an extension to this, manufacturers are working on developing improved, safer, and advanced blood-banking technologies for the collection, processing and delivery of blood products, further adding fuel to market growth.
The US constitutes the largest regional market for blood banking and blood products, as stated by the new market research report on Blood Banking & Blood Products. In the United States, while 2% of the population receives transfusions annually, another 15% undergo transfusion at least once in their lifetime. On an average, around 50-70 million units of blood, and blood components are transfused in developed countries every year. The developed markets are characterized by increased levels of public awareness, sophistication of blood collection technologies, and governmental support. While developed countries bank blood resources to suffice about 80% of their needs, blood supplies in the developing countries just suffice 40% of the requirements.
Increasing population in developing countries such as India and China, puts pressure on demand for blood on the blood bank segment. Governments of these countries are focused on enhancing healthcare delivery, which includes the blood bank segment. Resultantly, Asia-Pacific is projected to emerge as the fastest growing regional market over the analysis period.
Though blood and blood products provided by blood banks are free from viruses, bacteria, and other disease causing microorganisms, safety has become the main issue the world over. Risks involved in blood transfusion have also become a major issue in the blood banks, and blood products industry. Many companies are now visualizing blood decontamination as a step towards blood safety and availability. Though the process does not do away with the traditional blood screening, and donor exclusion programs, it is expected to prevent infected transmission. New processes are being developed to make blood supply safer. Areas such as blood filtration, and pathogen passivation methods are witnessing development. The need for safe, and suitable blood has been the driving force behind the blood banking, and blood products industry.
The global Blood Banking & Blood Products market is dominated by Blood Components and Plasma Products. The market for blood components and plasma products comprise of whole blood & cellular components, and plasma fractions. Equipment, blood tests, and other consumables are forecast to witness a compounded annual growth rate of more than 4.0% during the analysis period.
Leading blood banks profiled in the report include AABB, America’s Blood Centers, American Red Cross, Canadian Blood Services, Japan Red Cross Society, Lifebank Corp., New England Cord Blood Bank Inc., New York Blood Center, National Blood Foundation, among others. Major players profiled in blood bank technology and supplies space include Beckman Coulter Inc., Becton, Dickinson and Company, CSL Behring LLC, Daxor Corp., Fenwal Inc., Haemonetics Corp., Talecris Biotherapeutics, and ThermoGenesis Corp. Key players in plasma fractionation includes Baxter International, Bio Products Laboratory, CSL Ltd., Grifols, Kedrion, Octapharma, Sanquin, and others.
The report titled “Blood Banking & Blood Products: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of the blood banking and blood products market, current market trends, growth drivers, impact of recession on the industry, segment market analysis and potential, new product introductions/innovations, recent industry activity, and focus on major and niche global as well as regional market participants. The study analyzes market data and analytics in terms of value sales for global as well as regional markets including the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Product segments analyzed include Blood Components and Plasma Products (Whole Blood & Cellular Components, and Plasma Fractions), and Whole Blood & Cellular Components.
For more details about this comprehensive market research report, please visit –http://www.strategyr.com/Blood_Banking_and_Blood_Products_Market_Report.asp

Global market for surgical hemostats gets bloody!

By showing the pie chart below, with all of its overlapping labels and clutter, we do so not out of any lack of graphing skills but as a blunt reflection of how competitive the global market for surgical hemostats has become.

The number of competitors in this field has rapidly multiplied, driven by the relatively low barriers to market entry and the recent market success of a range of different hemostat product types that are being steadily adopted in clinical practice.  Hemostats have become accepted tools in the armamentaria of surgeons, both as stand alone products for stopping bleeding of traumatic and surgical wounds and as adjuncts to other wound sealing and closure technologies.
The natural course of proliferation inevitably leads to market consolidation and this is the short term prospect for products in hemostasis as well established players seek to literally buy greater market share and broaden their product portfolios.

Source: MedMarket Diligence, LLC; Report #S180 (pending publication).

EU Pricing Pressure Sure To Impact Hemostasis Market

"European governments grappling to reduce large budget deficits are focusing their cost-cutting on a large spending item - pharmaceuticals," The Wall Street Journal reports. "Several countries in recent weeks, including Spain, Germany and Italy, have proposed or enacted reductions in what they will pay or taken other cost-control measures for various drugs. ... In Europe, state healthcare systems pay for the bulk of drug purchases. European governments have long been known for their frugality when negotiating prices with drug companies, but the latest cuts are more severe than usual. Europe is the second largest market after the U.S. for many drug companies."
The European Federation of Pharmaceutical Industries and Associations, the industry's main lobbying body in Europe, is warning of the economic consequences. In a statement, the group said the cuts would "sharply diminish revenues to manufacturers...with an impact on their R&D investments. This in turn will impact European economic recovery and employment"

The dollar's climbing value threatens to pressure sales in coming quarters for U.S. medical-device and drug makers that are big exporters to Europe.
The greenback's rise--it's up about 15% against the euro this year--compounds worries already brewing that cash-strapped European governments, pressured by a debt crisis on the continent, will cut back on health-care spending.

For device companies, Piper Jaffray analyst Matt Miksic called the currency impact "manageable for most" because of hedging plans. He sees a 1% to 2% earnings impact this year.
The currency effects can be very complex. Many companies routinely give sales estimates that exclude the currency impact so that the business' performance isn't shrouded. Also, they typically employ a mix of natural and financial hedges to protect earnings, even if sales take a big hit.
Natural hedges can include overseas manufacturing capacity, which can put the cost of production in the same currency as sales. For big multinational companies doing business around the globe, currency values in different countries can sometimes have an offsetting effect. Then there are foreign- exchange contracts companies can enter to manage risk.
But the dollar's strength still adds strain. JPMorgan noted a trend over the past decade of device stocks performing better than the broader market when currency rates add to sales, but worse when currency is a negative factor. "In short, MedTech stocks seldom outperform in the face of an FX headwind," analyst Michael Weinstein said.
Some of the dollar's gains have come since companies reported first-quarter results in April; however, device-maker Medtronic's recent report offered some fresh perspective. The company, which posted sales of $15.8 billion for its year ended April 30, said exchange rates at Monday's level would dent sales by $400 million to $500 million in the new fiscal year.
But the company also said its hedging strategy should mostly shield earnings.
The backdrop to currency concerns is the threat European sales also will decline because of government spending cuts. But some big companies have downplayed this risk.
This is "spooking investors," Abbott Laboratories (ABT) Chief Executive Miles White said at a recent conference. He explained that Abbott factored pressure in Europe into its 2010 financial forecasts and that he doesn't plan to change them directly due to European woes.

Review of Topical Hemostatic Agents: Efficacy and Recommendations for Use.

Hemostat Market Research

• Category I: 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.
  
• Category II: 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).
  
• Category III: Cost-Effective and Time-Saving
  Immediate reduction in surgical treatment time and follow-up treatments.
  
• Category IV: 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.

Source: MedMarket Diligence, LLC

Orthovita Powerhouse validates future Hemostasis Growth

Orthovita have released convincing data relaying their belief in the Orthopedic hemostasis market......see below......

Changes ahead in the coagulation factor market by new entrants and technologies

The worldwide market of recombinant and plasma derived coagulation factors grew to more than US$ 7.5 bln in 2008 and will be fundamentally challenged by over 40 projects in the R&D pipeline

Barcelona, Spain | August 14, 2009 | The Business Intelligence firm La Merie S.L. conducted an analysis of the coagulation factor R&D pipeline and benchmarked the over 50 companies active in the field within their peer group. The study revealed that the total market of recombinant and plasma-derived products of more than US$ 7.5 bln in 2008 will be fundamentally challenged by new players with improved next generation molecules as well as with lower priced molecules without being biosimilars. In contrast to other therapeutic proteins, recombinant first generation coagulation factors VIII, IX and VIIa have not been replaced by longer acting successors right in time before patent expiration. Failure of life cycle management efforts further put at risk future growth rates of product sales. This allows new market entrants to position themselves on the same level as the established marketers. New recombinant coagulation factors, e.g von Willebrand factor, fibrinogen, thrombin and F. XIII are challenging plasma derived products, especially in the field of topically used haemostats as an aid to stop bleeding and tissue sealants for wound healing. As the current generation of novel coagulation factors is focused on modifying half-life, there remains room for further improvement by non-invasive delivery or by reducing immunogenicity.These results and more were found in the search conducted by La Merie Business Intelligence. The report can be acquired at La Merie’s online store (www.pipelinereview.com/store ).

The report “Coagulation Factors 2009: Target Pipeline and Corporate Benchmark Analysis” analyzes and assesses the target pipeline for each of the coagulation factors used for systemic and topical administration. Companies active in the therapeutic coagulation business are evaluated and the strengths, weaknesses, opportunities and threats (SWOT) in their R&D pipeline benchmarked in the respective peer group. Technologies used for creation of next generation coagulation factors are discussed and assessed. The report identifies strategies to overcome weaknesses in the portfolio and suggests development strategies.

Poll Result - Which Geographical Manufacturing Area for Hemostatic Devices Causes Concern?

Poll Result - Hemostatic Agents are utilized by myself or my customers primarily as?

Data is rounded to nearest full number.

Hemostat IFU and Brochure Downloads

For your information currently including J&J, Baxter, Vascular Solutions, Orthovita, SMI, Cryolife, further materials are welcomed along with updates (please send to hemostatguy@gmail.com) , all materials provided are and sent must be freely available online and from a verifiable email address. You may download or share by clicking on the thumbnails below..........Please Do view the sidebar Disclaimer also displayed below this post as all information is subject to change and is not for clinical use, always review the company/product information directly. No liability is accepted by this Author.

Disclaimer: All data and information provided on this site is for informational purposes only. I make no representations as to accuracy, completeness, currentness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use. All information is provided on an as-is basis.

Clinical Papers

Dear Reader,

I am inviting submissions for inclusion under the new label of "Clinical Papers" as per the paper below. If you have an article you feel would be useful or of interest please feel free to submit to me directly at hemostatguy@gmail.com

EMS, Surgical, Topical, Sealant, Glue and intravenous articles are all welcomed!

Clinical Benefits and Risks of Topical Hemostats: A Review

You may view or download by clicking on the thumbnail.

Analyst predicts - "high-strength, elastic glue without toxicity concerns would revolutionize the market"

Approximately 70 million surgical and procedure-based wounds are created each year in surgeries worldwide that offer potential for adjunctive products for surgical closure and securement. Some 23 million of these wounds are created during surgical procedures in the United States. Although it is possible that healing of all these wounds would be improved through use of adjunctive products for surgical closure and securement, use of the most advanced of these products has been limited to a fraction of these procedures. For example, there are approximately 3 million procedures which receive sealant products around the world, generating $1.6 billion in sales in 2007. We forecast much greater usage of sealants once clinical efficacy is proven in a broad range of procedures. New sealant products are also being launched. In addition to improvements in adjunctive treatment of bleeding, new procedure-enabling devices for soft tissue repair and securement have been introduced. These products have expanded the total market for securement and closure of soft tissues with bioresorbable materials.

This field is expanding rapidly as new devices allow the surgeon to perform closure more quickly and with improved outcomes for patients. A significant premium is possible when new products and devices enable complex securement procedures to be performed under minimally invasive protocols with significant time-savings in the operating room. New technologies and new biomaterials allow improved tissue repair, and it is possible to revalue segments of this market based on significant improvements in clinical practice. We expect this market segment to triple in value over the next decade.

The total market potential by 2013, driven by procedure volumes, for hemostats, sealants, and glues, addressable by currently available products, nearly $4.5 billion for hemostats and sealants, and more than $1.3 billion for skin wound closure using high-strength glues. The introduction of a high-strength, elastic glue without toxicity concerns would revolutionize the market further and lead to even higher sales potential.

Source: MedMarket Diligence, LLC

The Most Important Factor in a Hemostatic Agent - Poll Results

The Question for this Poll........"The Most Important Factor in a Hemostatic Agent is?".

Bit of a landslide for Efficacy with 50%. Following up was Safety with 23%, which is interesting when compared to our previous poll .

Cost was voted at 12% the equal of Ease of Use also with 12%.

Hemostasis Market - Review of Gelfoam, Surgicel, Avitene, Floseal, Bovine Thrombin

This post is to provide further commentary to a readily available 2005 article posted early last year from an online source. The source of the original article is linked below*.

So what do we want in a good hemostatic agent? First, the ideal hemostatic agent would of course be such that the agent itself is as well as any of its metabolic breakdown products would be safe to use within the body. Second, you want it to work and you want it to be efficacious.
The definition of efficacy can vary between the different uses, for example a vascular surgeon may want something that polymerizes very quickly in order to stop bleeding, but does not cause clot of the vessel that they spent all this time anastomosing, where as a reconstructive surgeon for example may want something that polymerizes very slowly to give them time to reposition their flaps or grafts.
Third is usability; you want something that is easy to use and that you can use in a variety of different circumstances. Fourth is affordability. This may be more relevant to a hospital administrator or pharmacist who actually does the purchasing, but it impacts the surgeon because that determines what you have available to you in the operating room. And finally, fifth, approvability. Any of these agents need to be approved by the FDA in order to be used in the US. So the different types of hemostatic agents, which I will be addressing in this talk are listed below and I am going to go through each one of these specifically.Gelatin sponge or Gelfoam®, which is also known as commercially as Surgifoam again was first introduced in the 1940s by Dr. Gray in the neurosurgical procedures. What it is is purified pork skin gelatin which you can kind think of like Jello®, as it is the same thing that Jello® is made out of.
It has a very amorphous form and has a lot of air spaces and it stains very eosinophilic on H&E stain. Basically the way it works is that its surface essentially acts in the intrinsic pathway causing contact activation and thus platelets. Since it works very proximally within this cascade, you have to have functioning cofactors or clotting factors in order for this to work in helping create clot. Of note, it does absorb approximately 45 times its weight in blood and can expand to approximately 200% of its initial volume. It is absorbed in approximately four to six weeks and on the nasal mucosa it liquifies within two to five days. In the case presentation, this child was initially packed with Gelfoam® approximately a week prior to the time she was seen in the ER and at that point there was no evidence of any Gelfoam left within her nasal cavity. Now the way Gelfoam® can be used, you can either apply dry, directly to the bleeding surface and hold pressure over it or you can wet it in saline and then squeeze out all the air bubbles and use it that way.
Oxidized regenerated cellulose is also known as Surgicel or Oxycel in its commercial forms. It is derived from alpha-cellulose that is actually plant-based. As you can see on microscopic view, Surgicel comes in knit formwhere as Oxycel comes in a microfibrillar form and on microscopic view Surgicel has these fibers which are knit together and they are solid fibers whereas Oxycel has the hollow fibers but they essentially work the same way. Surgicel is relatively acidic and is thought to cause some small vessel contraction. Like Gelfoam, it works at the same point in the intrinsic pathway of clotting causing contact activation. So again the same thing holds that functional clotting factors are needed in order for this to work. It is thought to berelatively bacteriostatic when compared to other hemostatic agents. The theory behind this is that because of its relatively low pH, it deactivates and denatures some of the bacterial proteins especially those related to antibiotic resistance, thus making them more susceptible to antibiotics. It needs to be applied dry and absorbs within four to eight weeks. Of note, on postop imaging Surgicel sometimes causes a ring-enhancing lesion as you can see here on postop imaging, which can be mistaken for an abscess cavity or tumor recurrence. That is something to keep in mind if you are imaging a patient within two months of having operated on them and Surgicel was used during the procedure. On microscopic view, you can see a giant cell reaction.
Our next agent is microfibrillar collagen commercially known as Avitene ®. It is most commonly used in a light flour form, but it does also come in a non-woven web form. This is collagen, which is derived from bovine skin. Under the microscope it is very eosinophilic and of note, under polarizing light it does have periodicity. It binds tightly to blood surfaces, so you do not actually need to achieve a relatively dry field in order to apply it. It causes minimal swelling especially when compared to Gelfoam ®. T he way it works is slightly different because in addition to being collagen and causing contact activation, it does somehow directly activate platelets. But again, it works very proximally within the intrinsic pathway. It is absorbed in three months and it needs to be applied dry.
Collagen sponges, these come in a wide variety of different commercial forms. Again it is similar to Avitene ® and it is derived from bovine Achilles tendon or bovine skin and it works in basically the exact same way as Avitene works and it absorbs in 8-10 weeks.
The next class of hemostatic agents is slightly different: topical thrombin. The idea of topical thrombin has been around since the early 1900s in order to try to achieve clot and in addition the idea of using topical thrombin plus other hemostatic agents such as Gelfoam ® has been around for quite a longtime. In 1999 a new agent was introduced called Floseal™ which basically consists of bovine thrombin plus cross-linked gelatin granules mixed together. So the way it works is your bovine thrombin directly activates fibrinogen and converts it into fibrin monomers. So you can see that this works in a completely different place within the clotting cascade. It works down here in the common pathway bypassing all of the other necessary clotting factors. You do however have to have functional fibrinogen in order for this to work. The product Floseal™ itself is a little bit different from just using topical thrombin plus Gelfoam ® because the gelatin granules have been cross linked in such a way that they do not swell to nearly the same extent. It is absorbed in approximately 6-8 weeks.
Fibrin sealants are the last class of the hemostatic agents that I am going to address. Commercially it comes in many forms including tisseal and crosseal and there are many variations on the idea of fibrin sealants. One of those basic ideas is that you take pure human fibrinogen and combine it with bovine thrombin and they usually throw in an antifibrinolyticagent into the mix as well. So the way this works is that we take the bovine thrombin, it then converts this exogenous human fibrinogen to fibrin monomers, but you do need intrinsic, you need the patient’s own factor XIII and calcium, which then converts it into fibrin polymer. In addition, they usually add an antifibrinolytic agent to the mix as well in order to stabilize the clot. So this does require functional factor XIII and calcium in order for these fibrin sealants to work. They are absorbed within 10-14 days and need a relatively dry field in order to work.
I am going to briefly mention some of the other classes of agents which are out there, but I am not going to address these in detail. There are some completely autologous fibrin sealants. The patient’s own serum is taken and the fibrinogen and thrombin are purified. This achieves essentially the same effect as the fibrin sealants previously mentioned. There are a target platelet gels where again you purify the platelet with plasma and the patient’s own serum combined with thrombin and you get similar agent to the fibrin sealants only there are some additional benefits: you do have some platelet direct growth factors involved which help with wound healing. There are some completely synthetic agents, which are made from polyethylene glycol gels that when you combine them make a completely synthetic hydrogel. Another product is bovine serum plus albumin plus glutaraldehyde, and poly N-acetyl glucosamine is something that the military is investigating as a hemostatic agent and it is a seaweed-based agent. This is just an idea of what is out there in addition to the agents I addressed previously.
Gelfoam ® and Surgicel, work here very proximally in the intrinsic coagulation pathway via contact activation. Collagen also works via contact activation, but also activates platelets. In a completely separate class we have agents that work in the common pathway, which includes Flowseal™, which is essentially topical thrombin and as well as fibrin glue and its variants.
Safety, three things to remember that Gelfoam® swells and it swells a lot. This has proven to be a problem when used within confined spaces such as the spinal foramina where in it can cause spinal cord nerve compression and brain compression. (Gelfoam adverse events HERE and HERE).
Surgicel, of note, even though it does have an antimicrobial effect relative to the other hemostatic agents, it is still a nidus for infection.( Links of interest HERE and Adverse events HERE and HERE and HERE ). Avitene®, and in fact all of these agents, do cause a certain amount of foreign body reaction and granulation formation. But Avitene® has been found to be the worst offender in this way. You can see in this particular slide, they have the Avitene® cavity here, and then a large amount of surrounding edema and a foreign body reaction with giant cells here surrounding the Avitene®. In this picture you can see the periodic nature of Avitene® under polarized light. In fact, the manufacturers recommend that you apply these agents, then hold pressure and wait a while for a clot to form and then you remove the agent afterwards so that you do not leave it within the cavity in order to try to prevent foreign body reaction as much as possible. In addition, Avitene® because it comes in a light fluffy form, has been known to occasionally cause arterial embolization and it had been reported that it is causing laryngospasm when used in tonsillectomy. Collagen sponge has many of the same side effects as any of the bovine derived agents because there are known allergic reactions to some of these bovine antigens, which are containing these agents. (Avitene adverse events HERE and HERE ).
Floseal™ again as I mentioned before has much less swelling than the Gelfoam so it can be used within some of the more enclosed spaces. Because it is Gelfoam beads it can cause arterial embolization if it is used near a larger vessel. In fact Gelfoam beads themselves have been used in order to embolize arterial malformation. Because it contains bovine antigens, it can have antibody formation, which I am going to talk about a little bit more in detail later. Some of the fibrin sealants use pooled human fibrinogen, in which there is always the potential for transmission of infectious agents. Also again, risks of arterial embolization and antibody formation. ( Floseal, Tisseel, CoSeal and Bioglue discussion HERE  and bioglue HERE).
Antithrombin antibodies: These are foreign antigens. A study of 200 patients showed 90% of those exposed to topical thrombin do have a transient elevation in IgG titers. Tadokoro et al in Japan also noted that you can have development of IgE antibodies. This can result in a prolonged thrombin time. Of note, thrombin time is actually a measure of fibrinogen count.
Thrombin time: the way this test was done, you add bovine thrombin to the patient’s fibrinogen and see how long it takes for it to form a monomer. Because you have development of antibodies to bovine thrombin, you can have elevation in your thrombin time. This antibovine thrombin antibody can cross-react with human thrombin, but interestingly enough, this rarely ever causes any sort of clinical bleeding.
The real problem is with antifactor V antibody, as most commercial form of thrombin is contaminated with a certain amount of other bovine antigens and most importantly bovine factor V. So if you can get these antibovine factor V antibodies, which then cross-react with human factor V this can lead to a very severe coagulopathy and because this antibody can act as an inhibitor of factor V. On laboratory tests you can find a very decreased factor V level, increased PT and PTT, which does not correct when you add FFP and vitamin K. When you mix the patient’s sera with a normal human sera, you do not get correction of the PT and PTT which suggest that it is not a cofactor deficiency, but it is actually an inhibitor causing the problem. So as you can see here the factor V is an activator of the conversion of prothrombin to thrombin and this is where you end up with problems. The same study noted that 50% of the 200 patients that they found that were exposed to topical thrombin did develop human factor V antibodies. The problem usually does not happen on the initial exposure, but it is when they are exposed again in the later point to the topical thrombin is when the potential for coagulopathy is exposed. Fortunately these IgG titers do fall off rapidly three to four weeks after the exposure and the treatment if you do encounter this is steroids, cyclophosphamides, IVIG plasmapheresis and platelet transfusion. Of note, I did not see actually any reports of this in the head and neck literature per se; most of the case reports of these events are in the cardiovascular and vascular literature. (Gelfoam or Thrombin adverse event HERE link of interest HERE . Of course we now have J&J human thrombin HERE and Zymogenetics recombinant HERE).
Another requirement of a good hemostatic agent is efficacy. Basically there have been lots of studies both in vitro and in vivo using various animal models as well as human studies comparing these various hemostatic agents. The general gist of them is that fibrin sealant work better than Floseal™ which is better than Avitene® and then the collagen sponge, Surgicel and Gelfoam® are essentially equivocal. They do work better than placebo but can barely differentiate efficacy between any of them. Of note, Floseal™ and Avitene® do cause more inflammatory reactions than the others.
Usability: Gelfoam®, Surgicel, Avitene® and these collagen sponge can be stored at the room temperature and are basically ready to use out of the box. Floseal™ does require two to five minute prep time, you combine the thrombin with calcium and combine that to the gelatin granules. Fibrin sealants on the other hand need to be kept in cold storage and thawed prior to usage; it depends on what company you are using and what type and the prep time can be anywhere up to 20-30 minutes. So it is something to keep in mind if you think you want to use fibrin sealant during your case you should be prepared ahead of time in order to do so.
Affordability: This is an average or sort of an idea of what the cost is for some of these agents. Gelfoam®, Surgicel, collagen sponges are relatively inexpensive in a $10-20 per individual piece, whereas Avitene®, Floseal™ and fibrin sealants are much more expensive.
Approvability: All of these agents are regulated through the FDA as a class III medical device, which means they are subjective to this medical device reporting systems so that the manufacturers are obligated to report to the FDA when an adverse event happens. In fact, in 2004 the FDA released notification to users about Gelfoam® and its swelling and use in neurosurgical procedures because of the potential for paralysis.
*The Full article is available HERE. Links have been added here regarding adverse events and are placed within parentheses.

There is a solution to many of the issues faced with Hemostat requirements with HaemoCer Plus.......read more HERE

Poll Results - Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?

We asked "Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?"

50% said YES

20% said NO

13% said DEPENDS ON THE COUNTRY OF ORIGIN OF PRODUCT

16% said MAYBE

Obviously human and animal sourced products do exhibit some concerns for many.