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Use of Tissue Sealants and Hemostatic Agents in Surgery Martha K. Terris, M.D. Medical College of Georgia
Hemostasis “life in the balance” CVA MI DVT PE Trauma Surgery Anticoagulation Hemophilia Bleeding to Death Clotting  to De...
 
Why Use Hemostatic Agents <ul><li>Minimize blood loss </li></ul><ul><li>Improve visualization </li></ul><ul><li>Save opera...
A Century of Hemostasis Surgeons today have an impressive set of tools to manage intra-operative bleeding. But how do you ...
History of Hemostasis <ul><li>Prior to 1900  </li></ul><ul><li>Prior to 1950 </li></ul>
Factors in Choosing a Hemostatic Agent <ul><li>Product cost </li></ul><ul><li>Availability </li></ul><ul><li>Storage </li>...
Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat)  - J&J ...
Materials Properties/Handling <ul><li>Mechanism of action </li></ul><ul><ul><li>Passive (aides platelet plug formation) </...
Site Characterization <ul><li>Area: large vs small </li></ul><ul><li>Intensity: light vs heavy </li></ul><ul><li>Accessibi...
 
Bleed
Bleed Collagen, ORC Flowable Gelatin Thrombin Fibrin Sealant
Bleed Platelet inhibitors, NSAIDS, ASA, Clopidogrel Thrombin inhibitors, Heparin, Warfarin tPA, uPA Trauma, Time, Us!
Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat)  - J&J ...
 
INSTAT  <ul><li>Instat Collagen  </li></ul><ul><li>(Absorbable Hemostat Sponge) </li></ul>Instat MCH (Microfibrillar Colla...
AVITENE Avitene Collagen Sponge (Absorbable Hemostat Sponge) Avitene MCH Flour (Microfibrillar Collagen Hemostat Powder)
Collagen INSTAT (J&J) and Avitene (Davol) <ul><li>Not widely used in urologic surgery </li></ul><ul><li>Plant-derived </li...
Avitene Applicators <ul><li>Extended applicators available for deeper open or laparoscopic application of Avitene </li></u...
Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat)  - J&J ...
Oxidized Regenerated Cellulose (ORC) <ul><li>Advantages </li></ul><ul><li>Multiple application formats (mesh, knit, fibril...
$12 $15 $20
How Does SURGICEL Work?
Why is SURGICEL Bactericidal?
SURGICEL <ul><li>Conforms to wound site, minimal sticking to gloves or instruments </li></ul><ul><li>Effective hemostasis ...
SURGICEL <ul><li>Can be passed down endoscopic instruments </li></ul>
SURGICEL SURGICEL Mesh adherent to area of bleeding SURGICEL Nu-Knit used to make bolsters for partial nephrectomy
SURGICEL Fibrillar Can be shredded, compacted, or moistened and molded to various shapes
 
Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat)  - J&J ...
GELFOAM/SURGIFOAM  <ul><li>Absorbable Gelatin </li></ul>SURGIFOAM Absorbable Gelatin Powder GELFOAM Absorbable Gelatin Spo...
GELFOAM/SURGIFOAM <ul><li>Addition of thrombin or saline allows molding to specific areas </li></ul><ul><li>Doesn’t stick ...
Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat)  - J&J ...
Flowable Gelatin <ul><li>Composition </li></ul><ul><li>Animal-derived gelatin mixed with thrombin (or saline) in a flowabl...
Flowable Mechanism of Action <ul><li>Applied to the tissue surface at the base of the lesion. Its granules fill the wound ...
Flowable Mechanism of Action <ul><li>Granules not incorporated in the clot can and should be removed with gentle irrigatio...
Flowable Gelatin <ul><li>Advantages </li></ul><ul><li>Rapid hemostasis </li></ul><ul><li>Precise application </li></ul><ul...
<ul><li>SURGIFLO </li></ul><ul><li>Uses human thrombin </li></ul><ul><li>Low risk of immune reaction </li></ul><ul><li>Pre...
Flowable Gelatins Surgiflo
Endoscopic Applicator for Flowable Gelatins <ul><li>Indicated for the endoscopic delivery of hemostatic agents </li></ul><...
Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat)  - J&J ...
Bleed Collagen, ORC Flowable Gelatin Thrombin Fibrin Sealant
Thrombin <ul><li>Bovine-derived or human thrombin (equivalent time to hemostasis): Thrombin, Evithrom, Recothrom </li></ul...
Thrombin <ul><li>Bovine </li></ul><ul><ul><li>Purified from pooled bovine plasma </li></ul></ul><ul><ul><li>Not 100% homol...
Bovine Thrombin <ul><li>Used in a wide variety of surgical procedures, estimated >500,000 Americans exposed each year </li...
Isolation of anti-Bovine Thrombin Antibodies 1989  90  91  92  93  94  95  96  97  98  99  00  01 Clinical Reports of Pati...
Pooled Human Plasma Products <ul><li>Primary risk is pathogen transmission </li></ul><ul><li>In 1977, FDA banned all comme...
 
Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat)  - J&J ...
History of Fibrin Sealants <ul><li>1909 – The use of fibrin to facilitate hemostasis was reported for the first time </li>...
Fibrin Sealants Target the Final Steps of the Coagulation Cascade
Thrombin and Fibrinogen <ul><li>Can be stored in separate vials at -18 o C for 2 years or refrigerated at 4 o C for 30 day...
Anti-Fibrinolytics <ul><li>Anti-fibrinolytics inhibit the formation of plasmin from plasminogen </li></ul><ul><li>Plasmin ...
Bleed Collagen, ORC Flowable Gelatin Thrombin Fibrin Sealant
US Indications by Brand <ul><li>Evicel – Adjunct to hemostasis for use in patients undergoing surgery when control of blee...
Fibrin Sealants <ul><li>EVICEL </li></ul><ul><li>Uses human thrombin (all human components) </li></ul><ul><li>Low risk of ...
Tisseel
Evicel
Tisseel
Fibrin Sealants <ul><li>Not indicated for treatment of severe or brisk bleeding </li></ul><ul><li>Do not inject directly i...
 
Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat)  - J&J ...
Synthetic Sealants <ul><li>Co-Seal and BioGlue most commonly used </li></ul><ul><li>Creates a shell over the area applied ...
BioGlue <ul><li>Composed of Glutaraldehyde and purified bovine serum albumin (BSA) </li></ul><ul><li>Binds covalently to t...
CoSeal <ul><li>Composed of two synthetic polyethylene glycols (PEGs) in hydrogen chloride and sodium phosphate </li></ul><...
Cost <ul><li>Avitene powder $625 (5ml) </li></ul><ul><li>Avitene sheets $350-550 </li></ul><ul><li>Surgicel $12-20 </li></...
“ All Bleeding Stops”
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Use Of Tissue Sealants And Hemostatic Agents

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Use Of Tissue Sealants And Hemostatic Agents

  1. 1. Use of Tissue Sealants and Hemostatic Agents in Surgery Martha K. Terris, M.D. Medical College of Georgia
  2. 2. Hemostasis “life in the balance” CVA MI DVT PE Trauma Surgery Anticoagulation Hemophilia Bleeding to Death Clotting to Death
  3. 4. Why Use Hemostatic Agents <ul><li>Minimize blood loss </li></ul><ul><li>Improve visualization </li></ul><ul><li>Save operative time </li></ul><ul><li>Reduce or avoid transfusion </li></ul><ul><li>Manage anticoagulated patient </li></ul><ul><li>Avoid conversion of lap procedures </li></ul><ul><li>Prevent leakage of non-bloody fluids </li></ul><ul><li>Decrease post-op drainage and infection </li></ul><ul><li>Decrease hospital length of stay </li></ul>
  4. 5. A Century of Hemostasis Surgeons today have an impressive set of tools to manage intra-operative bleeding. But how do you know what to use? 1900 1950 2000 Clamps Clips Sutures Direct Compression Bone wax Electrocautery Laser Argon beam ORC Gelatin Thrombin Flowable gelatin Fibrin Sealants Synthetic Sealants
  5. 6. History of Hemostasis <ul><li>Prior to 1900 </li></ul><ul><li>Prior to 1950 </li></ul>
  6. 7. Factors in Choosing a Hemostatic Agent <ul><li>Product cost </li></ul><ul><li>Availability </li></ul><ul><li>Storage </li></ul><ul><li>Procedural applicability </li></ul><ul><li>Format (sponge, fabric, powder, paste, liquid) </li></ul><ul><li>Preparation </li></ul><ul><li>Delivery </li></ul><ul><li>Speed to hemostasis </li></ul><ul><li>Durability of hemostasis </li></ul><ul><li>Source (bovine, porcine, human, plant) </li></ul><ul><li>Immunogenicity </li></ul><ul><li>Impact on infection/healing </li></ul><ul><li>Absorption rate </li></ul><ul><li>Swelling </li></ul>
  7. 8. Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat) - J&J </li></ul></ul><ul><ul><li>Avitene MCH – Davol (Bard) </li></ul></ul><ul><li>ORC (Oxidized Regenerated Cellulose) </li></ul><ul><ul><li>Surgicel – J&J/Ethicon </li></ul></ul><ul><li>Gelatin </li></ul><ul><ul><li>Gelfoam – Pfizer/Baxter </li></ul></ul><ul><ul><li>Surgifoam – J&J </li></ul></ul><ul><li>Flowable Gelatins </li></ul><ul><ul><li>Floseal - Baxter </li></ul></ul><ul><ul><li>Surgiflow - J&J </li></ul></ul><ul><li>Thrombin </li></ul><ul><ul><li>Thrombin – King Pharma </li></ul></ul><ul><ul><li>Evithrom – J&J </li></ul></ul><ul><ul><li>Recothrom – Zymogenetics </li></ul></ul><ul><li>Fibrin Sealants </li></ul><ul><ul><li>Tisseel – Baxter </li></ul></ul><ul><ul><li>Evicel – J&J </li></ul></ul><ul><li>Synthetic Sealants </li></ul><ul><ul><li>Bioglue – Cryolife </li></ul></ul><ul><ul><li>Duraseal – Tyco </li></ul></ul><ul><ul><li>CoSeal – Baxter </li></ul></ul><ul><ul><li>Omnex – J&J/Ethicon (Europe only) </li></ul></ul><ul><ul><li>LifeBond – (FDA approval pending) </li></ul></ul>
  8. 9. Materials Properties/Handling <ul><li>Mechanism of action </li></ul><ul><ul><li>Passive (aides platelet plug formation) </li></ul></ul><ul><ul><li>Active (aides fibrin clot formation) </li></ul></ul><ul><li>Application format </li></ul><ul><ul><li>Fabric </li></ul></ul><ul><ul><ul><li>Woven (suturable vs see-through) </li></ul></ul></ul><ul><ul><ul><li>Non-woven (layers vs peanuts vs cigars) </li></ul></ul></ul><ul><ul><li>Flowable </li></ul></ul><ul><ul><ul><li>Paste (spread with fingers) </li></ul></ul></ul><ul><ul><ul><li>Slurry (apply with syringe) </li></ul></ul></ul><ul><ul><li>Liquid </li></ul></ul><ul><ul><ul><li>Drip (controlled delivery) </li></ul></ul></ul><ul><ul><ul><li>Spray (broad coverage) </li></ul></ul></ul>
  9. 10. Site Characterization <ul><li>Area: large vs small </li></ul><ul><li>Intensity: light vs heavy </li></ul><ul><li>Accessibility: open vs confined </li></ul><ul><li>Surface type: raw vs smooth </li></ul>
  10. 12. Bleed
  11. 13. Bleed Collagen, ORC Flowable Gelatin Thrombin Fibrin Sealant
  12. 14. Bleed Platelet inhibitors, NSAIDS, ASA, Clopidogrel Thrombin inhibitors, Heparin, Warfarin tPA, uPA Trauma, Time, Us!
  13. 15. Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat) - J&J </li></ul></ul><ul><ul><li>Avitene MCH – Davol (Bard) </li></ul></ul><ul><li>ORC (Oxidized Regenerated Cellulose) </li></ul><ul><ul><li>Surgicel – J&J/Ethicon </li></ul></ul><ul><li>Gelatin </li></ul><ul><ul><li>Gelfoam – Pfizer/Baxter </li></ul></ul><ul><ul><li>Surgifoam – J&J </li></ul></ul><ul><li>Flowable Gelatins </li></ul><ul><ul><li>Floseal - Baxter </li></ul></ul><ul><ul><li>Surgiflow - J&J </li></ul></ul><ul><li>Thrombin </li></ul><ul><ul><li>Thrombin – King Pharma </li></ul></ul><ul><ul><li>Evithrom – J&J </li></ul></ul><ul><ul><li>Recothrom – Zymogenetics </li></ul></ul><ul><li>Fibrin Sealants </li></ul><ul><ul><li>Tisseel – Baxter </li></ul></ul><ul><ul><li>Evicel – J&J </li></ul></ul><ul><li>Synthetic Sealants </li></ul><ul><ul><li>Bioglue – Cryolife </li></ul></ul><ul><ul><li>Duraseal – Tyco </li></ul></ul><ul><ul><li>CoSeal – Baxter </li></ul></ul><ul><ul><li>Omnex – J&J/Ethicon (Europe only) </li></ul></ul><ul><ul><li>LifeBond – (FDA approval pending) </li></ul></ul>
  14. 17. INSTAT <ul><li>Instat Collagen </li></ul><ul><li>(Absorbable Hemostat Sponge) </li></ul>Instat MCH (Microfibrillar Collagen Hemostat Powder)
  15. 18. AVITENE Avitene Collagen Sponge (Absorbable Hemostat Sponge) Avitene MCH Flour (Microfibrillar Collagen Hemostat Powder)
  16. 19. Collagen INSTAT (J&J) and Avitene (Davol) <ul><li>Not widely used in urologic surgery </li></ul><ul><li>Plant-derived </li></ul><ul><li>Available as sponge or powder </li></ul><ul><li>Can be used dry or wet, cut, sutured, wrapped </li></ul><ul><li>Won’t adhere to wet instruments or gloves </li></ul><ul><li>Hemostasis in 3-5 minutes </li></ul>
  17. 20. Avitene Applicators <ul><li>Extended applicators available for deeper open or laparoscopic application of Avitene </li></ul><ul><li>Use a syringe of air to clear any product still in applicator </li></ul>
  18. 21. Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat) - J&J </li></ul></ul><ul><ul><li>Avitene MCH – Davol (Bard) </li></ul></ul><ul><li>ORC (Oxidized Regenerated Cellulose) </li></ul><ul><ul><li>Surgicel – J&J/Ethicon </li></ul></ul><ul><li>Gelatin </li></ul><ul><ul><li>Gelfoam – Pfizer/Baxter </li></ul></ul><ul><ul><li>Surgifoam – J&J </li></ul></ul><ul><li>Flowable Gelatins </li></ul><ul><ul><li>Floseal - Baxter </li></ul></ul><ul><ul><li>Surgiflow - J&J </li></ul></ul><ul><li>Thrombin </li></ul><ul><ul><li>Thrombin – King Pharma </li></ul></ul><ul><ul><li>Evithrom – J&J </li></ul></ul><ul><ul><li>Recothrom – Zymogenetics </li></ul></ul><ul><li>Fibrin Sealants </li></ul><ul><ul><li>Tisseel – Baxter </li></ul></ul><ul><ul><li>Evicel – J&J </li></ul></ul><ul><li>Synthetic Sealants </li></ul><ul><ul><li>Bioglue – Cryolife </li></ul></ul><ul><ul><li>Duraseal – Tyco </li></ul></ul><ul><ul><li>CoSeal – Baxter </li></ul></ul><ul><ul><li>Omnex – J&J/Ethicon (Europe only) </li></ul></ul><ul><ul><li>LifeBond – (FDA approval pending) </li></ul></ul>
  19. 22. Oxidized Regenerated Cellulose (ORC) <ul><li>Advantages </li></ul><ul><li>Multiple application formats (mesh, knit, fibrillar) </li></ul><ul><li>Plant-derived </li></ul><ul><li>Minimal tissue reaction </li></ul><ul><li>Bactericidal </li></ul><ul><li>Disadvantages </li></ul><ul><li>Swelling can cause pressure on adjacent structures </li></ul><ul><li>Impairs bone healing </li></ul>Absorbs Fluids Causes platelet plug formation
  20. 23. $12 $15 $20
  21. 24. How Does SURGICEL Work?
  22. 25. Why is SURGICEL Bactericidal?
  23. 26. SURGICEL <ul><li>Conforms to wound site, minimal sticking to gloves or instruments </li></ul><ul><li>Effective hemostasis for classic 6-8 minutes, Nu-knit 3-5 minutes, fibrillar 3-4 minutes </li></ul><ul><li>No immunogenicity potential, bactericidal </li></ul><ul><li>Absorption within 7-14 days (depending on amount used, degree of saturation with blood) </li></ul>
  24. 27. SURGICEL <ul><li>Can be passed down endoscopic instruments </li></ul>
  25. 28. SURGICEL SURGICEL Mesh adherent to area of bleeding SURGICEL Nu-Knit used to make bolsters for partial nephrectomy
  26. 29. SURGICEL Fibrillar Can be shredded, compacted, or moistened and molded to various shapes
  27. 31. Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat) - J&J </li></ul></ul><ul><ul><li>Avitene MCH – Davol (Bard) </li></ul></ul><ul><li>ORC (Oxidized Regenerated Cellulose) </li></ul><ul><ul><li>Surgicel – J&J/Ethicon </li></ul></ul><ul><li>Gelatin </li></ul><ul><ul><li>Gelfoam – Pfizer/Baxter </li></ul></ul><ul><ul><li>Surgifoam – J&J </li></ul></ul><ul><li>Flowable Gelatins </li></ul><ul><ul><li>Floseal - Baxter </li></ul></ul><ul><ul><li>Surgiflow - J&J </li></ul></ul><ul><li>Thrombin </li></ul><ul><ul><li>Thrombin – King Pharma </li></ul></ul><ul><ul><li>Evithrom – J&J </li></ul></ul><ul><ul><li>Recothrom – Zymogenetics </li></ul></ul><ul><li>Fibrin Sealants </li></ul><ul><ul><li>Tisseel – Baxter </li></ul></ul><ul><ul><li>Evicel – J&J </li></ul></ul><ul><li>Synthetic Sealants </li></ul><ul><ul><li>Bioglue – Cryolife </li></ul></ul><ul><ul><li>Duraseal – Tyco </li></ul></ul><ul><ul><li>CoSeal – Baxter </li></ul></ul><ul><ul><li>Omnex – J&J/Ethicon (Europe only) </li></ul></ul><ul><ul><li>LifeBond – (FDA approval pending) </li></ul></ul>
  28. 32. GELFOAM/SURGIFOAM <ul><li>Absorbable Gelatin </li></ul>SURGIFOAM Absorbable Gelatin Powder GELFOAM Absorbable Gelatin Sponge SURGIFOAM Absorbable Gelatin Sponge
  29. 33. GELFOAM/SURGIFOAM <ul><li>Addition of thrombin or saline allows molding to specific areas </li></ul><ul><li>Doesn’t stick to gloves, instruments, can be passed down endoscopic instruments </li></ul><ul><li>Fast hemostasis </li></ul><ul><li>Minimal foreign body reaction </li></ul><ul><li>Absorbs in 4-6 weeks </li></ul>
  30. 34. Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat) - J&J </li></ul></ul><ul><ul><li>Avitene MCH – Davol (Bard) </li></ul></ul><ul><li>ORC (Oxidized Regenerated Cellulose) </li></ul><ul><ul><li>Surgicel – J&J/Ethicon </li></ul></ul><ul><li>Gelatin </li></ul><ul><ul><li>Gelfoam – Pfizer/Baxter </li></ul></ul><ul><ul><li>Surgifoam – J&J </li></ul></ul><ul><li>Flowable Gelatins </li></ul><ul><ul><li>Floseal - Baxter </li></ul></ul><ul><ul><li>Surgiflow - J&J </li></ul></ul><ul><li>Thrombin </li></ul><ul><ul><li>Thrombin – King Pharma </li></ul></ul><ul><ul><li>Evithrom – J&J </li></ul></ul><ul><ul><li>Recothrom – Zymogenetics </li></ul></ul><ul><li>Fibrin Sealants </li></ul><ul><ul><li>Tisseel – Baxter </li></ul></ul><ul><ul><li>Evicel – J&J </li></ul></ul><ul><li>Synthetic Sealants </li></ul><ul><ul><li>Bioglue – Cryolife </li></ul></ul><ul><ul><li>Duraseal – Tyco </li></ul></ul><ul><ul><li>CoSeal – Baxter </li></ul></ul><ul><ul><li>Omnex – J&J/Ethicon (Europe only) </li></ul></ul><ul><ul><li>LifeBond – (FDA approval pending) </li></ul></ul>
  31. 35. Flowable Gelatin <ul><li>Composition </li></ul><ul><li>Animal-derived gelatin mixed with thrombin (or saline) in a flowable consistency </li></ul><ul><li>Mode of action </li></ul><ul><li>Gelatin provides a matrix for platelet adhesion and aggregation </li></ul><ul><li>Thrombin aids in fibrin clot formation </li></ul><ul><li>Will not work if the area is not actively bleeding </li></ul>
  32. 36. Flowable Mechanism of Action <ul><li>Applied to the tissue surface at the base of the lesion. Its granules fill the wound and conform to its shape. </li></ul><ul><li>Granules expand approximately 20% within about 10 min and restrict the flow of blood. Blood that percolates through the spaces is exposed to high concentrations of thrombin. </li></ul><ul><li>A clot forms around the matrix provided by the granules and remains in place at the tissue surface. </li></ul>
  33. 37. Flowable Mechanism of Action <ul><li>Granules not incorporated in the clot can and should be removed with gentle irrigation </li></ul><ul><li>Absorbed within 6-8 weeks </li></ul>
  34. 38. Flowable Gelatin <ul><li>Advantages </li></ul><ul><li>Rapid hemostasis </li></ul><ul><li>Precise application </li></ul><ul><li>75% more tissue contact than traditional gelatin sponge </li></ul><ul><li>Flowable </li></ul><ul><li>Absorbable in 4-8 weeks </li></ul><ul><li>Disadvantages </li></ul><ul><li>Allergic potential (when bovine thrombin is used) </li></ul><ul><li>Swells 20% as it absorbs fluid </li></ul><ul><li>Preparation time </li></ul><ul><li>Cost </li></ul>
  35. 39. <ul><li>SURGIFLO </li></ul><ul><li>Uses human thrombin </li></ul><ul><li>Low risk of immune reaction </li></ul><ul><li>Prep time: 30 minutes </li></ul><ul><li>FLOSEAL </li></ul><ul><li>Uses bovine thrombin </li></ul><ul><li>Higher risk of immune reaction </li></ul><ul><li>Prep time: 60 minutes </li></ul>Flowable Gelatin
  36. 40. Flowable Gelatins Surgiflo
  37. 41. Endoscopic Applicator for Flowable Gelatins <ul><li>Indicated for the endoscopic delivery of hemostatic agents </li></ul><ul><li>Narrow cannula allows precise application of more product </li></ul><ul><li>Use stylet or syringe with air to express any remaining product out of applicator </li></ul><ul><li>$1500, reusable </li></ul>
  38. 42. Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat) - J&J </li></ul></ul><ul><ul><li>Avitene MCH – Davol (Bard) </li></ul></ul><ul><li>ORC (Oxidized Regenerated Cellulose) </li></ul><ul><ul><li>Surgicel – J&J/Ethicon </li></ul></ul><ul><li>Gelatin </li></ul><ul><ul><li>Gelfoam – Pfizer/Baxter </li></ul></ul><ul><ul><li>Surgifoam – J&J </li></ul></ul><ul><li>Flowable Gelatins </li></ul><ul><ul><li>Floseal - Baxter </li></ul></ul><ul><ul><li>Surgiflow - J&J </li></ul></ul><ul><li>Thrombin </li></ul><ul><ul><li>Thrombin – King Pharma </li></ul></ul><ul><ul><li>Evithrom – J&J </li></ul></ul><ul><ul><li>Recothrom – Zymogenetics </li></ul></ul><ul><li>Fibrin Sealants </li></ul><ul><ul><li>Tisseel – Baxter </li></ul></ul><ul><ul><li>Evicel – J&J </li></ul></ul><ul><li>Synthetic Sealants </li></ul><ul><ul><li>Bioglue – Cryolife </li></ul></ul><ul><ul><li>Duraseal – Tyco </li></ul></ul><ul><ul><li>CoSeal – Baxter </li></ul></ul><ul><ul><li>Omnex – J&J/Ethicon (Europe only) </li></ul></ul><ul><ul><li>LifeBond – (FDA approval pending) </li></ul></ul>
  39. 43. Bleed Collagen, ORC Flowable Gelatin Thrombin Fibrin Sealant
  40. 44. Thrombin <ul><li>Bovine-derived or human thrombin (equivalent time to hemostasis): Thrombin, Evithrom, Recothrom </li></ul><ul><li>Converts patient fibrinogen to fibrin </li></ul><ul><li>Available in a freeze-dried lyophilized powder that can be stored at room temperature but must be mixed </li></ul><ul><li>Liquid versions must be refrigerated </li></ul><ul><li>Multiple application techniques available (soaked in other products, spray) </li></ul><ul><li>Expensive </li></ul>
  41. 45. Thrombin <ul><li>Bovine </li></ul><ul><ul><li>Purified from pooled bovine plasma </li></ul></ul><ul><ul><li>Not 100% homologous with human thrombin </li></ul></ul><ul><ul><li>Bovine thrombin & factor V contain carbohydrate groups that are inherently immunogenic in humans </li></ul></ul><ul><li>Recombinant Human </li></ul><ul><ul><li>Human prothrombin gene is spliced into Chinese hamster ovary (CHO) cells </li></ul></ul><ul><ul><li>CHO cells make human prothrombin </li></ul></ul><ul><ul><li>Prothrombin activated with snake venom enzyme (cleaves prothrombin to thrombin) </li></ul></ul><ul><li>Human </li></ul><ul><ul><li>Purified from pooled human plasma </li></ul></ul><ul><ul><li>Viral transmission risk </li></ul></ul>
  42. 46. Bovine Thrombin <ul><li>Used in a wide variety of surgical procedures, estimated >500,000 Americans exposed each year </li></ul><ul><li>Anaphylactic deaths reported from use in vascular surgery resulting in black box warning from FDA </li></ul>
  43. 47. Isolation of anti-Bovine Thrombin Antibodies 1989 90 91 92 93 94 95 96 97 98 99 00 01 Clinical Reports of Patients with Major Complications from Antibodies Prospective Analysis of Thrombin Exposure in Surgical Patients Autoimmune Processes Linked with Use of Bovine Thrombin
  44. 48. Pooled Human Plasma Products <ul><li>Primary risk is pathogen transmission </li></ul><ul><li>In 1977, FDA banned all commercially prepared human fibrinogen preparations because of the high rate of disease transmission (HBV) </li></ul><ul><li>In 1998, FDA lifted this ban due to improved methods for plasma protein purification </li></ul>
  45. 50. Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat) - J&J </li></ul></ul><ul><ul><li>Avitene MCH – Davol (Bard) </li></ul></ul><ul><li>ORC (Oxidized Regenerated Cellulose) </li></ul><ul><ul><li>Surgicel – J&J/Ethicon </li></ul></ul><ul><li>Gelatin </li></ul><ul><ul><li>Gelfoam – Pfizer/Baxter </li></ul></ul><ul><ul><li>Surgifoam – J&J </li></ul></ul><ul><li>Flowable Gelatins </li></ul><ul><ul><li>Floseal - Baxter </li></ul></ul><ul><ul><li>Surgiflow - J&J </li></ul></ul><ul><li>Thrombin </li></ul><ul><ul><li>Thrombin – King Pharma </li></ul></ul><ul><ul><li>Evithrom – J&J </li></ul></ul><ul><ul><li>Recothrom – Zymogenetics </li></ul></ul><ul><li>Fibrin Sealants </li></ul><ul><ul><li>Tisseel – Baxter </li></ul></ul><ul><ul><li>Evicel – J&J </li></ul></ul><ul><li>Synthetic Sealants </li></ul><ul><ul><li>Bioglue – Cryolife </li></ul></ul><ul><ul><li>Duraseal – Tyco </li></ul></ul><ul><ul><li>CoSeal – Baxter </li></ul></ul><ul><ul><li>Omnex – J&J/Ethicon (Europe only) </li></ul></ul><ul><ul><li>LifeBond – (FDA approval pending) </li></ul></ul>
  46. 51. History of Fibrin Sealants <ul><li>1909 – The use of fibrin to facilitate hemostasis was reported for the first time </li></ul><ul><li>1944 – Plasma derived fibrinogen and thrombin were used to enhance adherence of skin grafts </li></ul><ul><li>1972 – Highly concentrated fibrinogen made from frozen plasma used to perform nerve anastomosis </li></ul><ul><li>1975 – First clinical reports of autologous fibrin sealant published in Europe </li></ul><ul><li>1981 – Fibrin sealant consisting of human thrombin, highly stabilized human fibrinogen with enriched factor XIII introduced </li></ul>
  47. 52. Fibrin Sealants Target the Final Steps of the Coagulation Cascade
  48. 53. Thrombin and Fibrinogen <ul><li>Can be stored in separate vials at -18 o C for 2 years or refrigerated at 4 o C for 30 days </li></ul><ul><li>Can be thawed at room temperature or in 37 o C water bath </li></ul><ul><li>Dual delivery systems design to prevent mixing of the two until contact with the target tissue </li></ul>
  49. 54. Anti-Fibrinolytics <ul><li>Anti-fibrinolytics inhibit the formation of plasmin from plasminogen </li></ul><ul><li>Plasmin breaks down the fibrin clot </li></ul><ul><li>Tisseel contains aprotinin, an antifibrinolytic </li></ul><ul><li>Plasminogen has been removed from Evicel through an extra step in the manufacturing process and therefore does not need an antifibrinolytic agent to prevent the formation of plasmin and subsequent breakdown of the fibrin clot. </li></ul>
  50. 55. Bleed Collagen, ORC Flowable Gelatin Thrombin Fibrin Sealant
  51. 56. US Indications by Brand <ul><li>Evicel – Adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical. </li></ul><ul><li>Tisseel – Adjunct to hemostasis in surgeries involving heparinized patients undergoing cardiopulmonary bypass and treatment of splenic injury due to blunt or penetrating trauma when control of bleeding by standard surgical techniques is ineffective or impractical. Also an effective sealant in closure of colostomies. </li></ul>
  52. 57. Fibrin Sealants <ul><li>EVICEL </li></ul><ul><li>Uses human thrombin (all human components) </li></ul><ul><li>Low risk of immune reaction </li></ul><ul><li>No aprotinin or tansexamanic acid </li></ul><ul><li>Prep time <1 minute </li></ul><ul><li>Clear clot </li></ul><ul><li>Spray or drip </li></ul><ul><li>TISSEEL </li></ul><ul><li>Uses bovine thrombin </li></ul><ul><li>Higher risk of immune reaction </li></ul><ul><li>Contains aprotinin </li></ul><ul><li>Prep time 15 minutes </li></ul><ul><li>Cloudy white clot </li></ul><ul><li>Spray (syringe or pressure delivery) or drip </li></ul>
  53. 58. Tisseel
  54. 59. Evicel
  55. 60. Tisseel
  56. 61. Fibrin Sealants <ul><li>Not indicated for treatment of severe or brisk bleeding </li></ul><ul><li>Do not inject directly into vascular structures or organs </li></ul><ul><li>Can apply in multiple layers </li></ul><ul><li>OK to use cautery or suture through layers of sealant </li></ul><ul><li>Clot longevity is comparable for both Tisseel and Evicel </li></ul>
  57. 63. Hemostasis and Sealing Market <ul><li>Collagen </li></ul><ul><ul><li>INSTAT MCH (Microfibrillar Collagen Hemostat) - J&J </li></ul></ul><ul><ul><li>Avitene MCH – Davol (Bard) </li></ul></ul><ul><li>ORC (Oxidized Regenerated Cellulose) </li></ul><ul><ul><li>Surgicel – J&J/Ethicon </li></ul></ul><ul><li>Gelatin </li></ul><ul><ul><li>Gelfoam – Pfizer/Baxter </li></ul></ul><ul><ul><li>Surgifoam – J&J </li></ul></ul><ul><li>Flowable Gelatins </li></ul><ul><ul><li>Floseal - Baxter </li></ul></ul><ul><ul><li>Surgiflow - J&J </li></ul></ul><ul><li>Thrombin </li></ul><ul><ul><li>Thrombin – King Pharma </li></ul></ul><ul><ul><li>Evithrom – J&J </li></ul></ul><ul><ul><li>Recothrom – Zymogenetics </li></ul></ul><ul><li>Fibrin Sealants </li></ul><ul><ul><li>Tisseel – Baxter </li></ul></ul><ul><ul><li>Evicel – J&J </li></ul></ul><ul><li>Synthetic Sealants </li></ul><ul><ul><li>Bioglue – Cryolife </li></ul></ul><ul><ul><li>Duraseal – Tyco </li></ul></ul><ul><ul><li>CoSeal – Baxter </li></ul></ul><ul><ul><li>Omnex – J&J/Ethicon (Europe only) </li></ul></ul><ul><ul><li>LifeBond – (FDA approval pending) </li></ul></ul>
  58. 64. Synthetic Sealants <ul><li>Co-Seal and BioGlue most commonly used </li></ul><ul><li>Creates a shell over the area applied </li></ul><ul><li>Caution not to cover things that will be removed </li></ul>
  59. 65. BioGlue <ul><li>Composed of Glutaraldehyde and purified bovine serum albumin (BSA) </li></ul><ul><li>Binds covalently to tissue surface proteins (won’t work if place on non-protein surface) </li></ul><ul><li>Supplied with multiple syringe tips as they clot off as soon as there is no active injection. </li></ul>
  60. 66. CoSeal <ul><li>Composed of two synthetic polyethylene glycols (PEGs) in hydrogen chloride and sodium phosphate </li></ul><ul><li>When mixed the PEGS form a hydrogel that adheres to tissue and covalently bonds to itself </li></ul><ul><li>Completely synthetic, no gluteraldehyde </li></ul><ul><li>Swells up to 4 times its volume in 24 hrs and additional swelling may occur as the gel resorbs </li></ul>
  61. 67. Cost <ul><li>Avitene powder $625 (5ml) </li></ul><ul><li>Avitene sheets $350-550 </li></ul><ul><li>Surgicel $12-20 </li></ul><ul><li>Gelfoam $80-120 </li></ul><ul><li>Floseal $262 (5ml) </li></ul><ul><li>Bovine Thrombin $80 (5ml) </li></ul><ul><li>Evithrom $95 (5ml) </li></ul><ul><li>Recothrom $110 (5ml) </li></ul><ul><li>Tisseel $220 (4ml) </li></ul><ul><li>Evicel $340 (4ml) </li></ul><ul><li>BioGlue $325 (5ml) </li></ul><ul><li>CoSeal $630 (4ml) </li></ul>
  62. 68. “ All Bleeding Stops”

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