Biosurgicals and Hemostasis

Biosurgicals and Hemostasis
David M. Albala, M.D.
Chief of Urology
Crouse Hospital
Syracuse, New York
Hemostasis
“life in the balance”
Bleeding to Death
Trauma
Major Surgery
Hemophilia
Clotting to Death
Stroke
MI
Thrombosis
Why Use Hemostatic agents?
• Minimize blood loss
• Improve visualization
• Save operative time
• Reduce or avoid transfusion
• Manage anticoagulated patients
• Enable or avoid conversion of lap procedures
• Prevent leakage of non-bloody fluids
• Decrease post-op drainage and infection
• Decrease hospital length of stay
A Century of Hemostasis
1950
1900
Clamps
Clips
Sutures
2000
Direct compression
Bone wax
Electrocautery LASER Argon beam coagulation
ORC
Gelatin
Collagen
Thrombin
Flowable Gelatin
Surgeons today have an
impressive set of tools to
manage intra-operative
bleeding. But how do you
know what to use?
Fibrin Sealants
Synthetic Sealants
Factors in Choosing a Hemostatic Agent
•
•
•
•
•
Product Cost
Availability
Storage
Procedural applicability
Format (sponge, fabric,
powder, paste, liquid)
• Preparation
• Delivery
• Speed to hemostasis
• Durability of hemostasis
• Source (bovine, porcine,
human, plant)
• Immunogenicity
• Impact on infection/healing
• Absorption rate
• Swelling
Hemostasis & Sealing Market
TOPICAL ABSORBABLE HEMOSTATS
Traditional Hemostats
ADVANCED HEMOSTATS AND SEALANTS
Advanced Hemostats
COLLAGEN
ORC
GELATIN
FLOWABLE
THROMBIN
FIBRIN
SYN.SEALANT
INSTAT™
MCH
Microfibrillar
Collagen
Hemostat
SURGICEL®
Family of
Absorbable
Hemostats
SURGIFOAM™
Family of
Absorbable
Hemostats
SURGIFLO®
Hemostatic
Matrix
EVITHROM™
Thrombin,
Topical
(Human)
EVICELTM
Fibrin
Sealant
(Human)
ETHICON
OMNEX™
Surgical
Sealant
(In Europe
Only)
Gelfoam®
PFIZER/BAXTER
FloSeal® HT
BAXTER
Thrombin-JMI®
KING PHARMA
&
Recothrom®
ZYMOGENETICS
TISSEEL®
BAXTER
Avitene®
DAVOL
CoSeal®
BAXTER
BioGlue®
CRYOLIFE
DuraSeal®
TYCO
Material Properties/Handling
• Mechanism of action
• Passive (aids platelet plug formation)
• Active (aids fibrin clot formation)
• Combination
• Application format
• Fabric
Ø
Ø
Woven (suturable vs see-through)
Non-woven (layers vs peanuts vs cigars)
• Flowable
Ø
Ø
Paste (spread with fingers)
Slurry (apply with syringe)
• Liquid
Ø
Ø
Drip (controlled delivery)
Spray (broad coverage)
Site Characterization
•Area: large vs small
•Intensity: light vs heavy
•Accessibility: open vs confined
•Surface type: raw vs smooth
The Hemostatic Cascade
The Hemostatic Cascade
11
Hemostatic Agents and the Cascade
§ Provides a matrix for platelet
adhesion and aggregation
ORC
§ Aids in fibrin clot formation
THROMBIN
FLOWABLE GELATIN
§ Provides a matrix for platelet
adhesion and aggregation
§ Aids in fibrin clot formation when
used with thrombin
FIBRIN SEALANT
§ Provides all the components necessary
for fibrin clot formation
12
Anticoagulants
and
the Cascade
Anticoagulants
and the
Cascade
HEPARIN
THROMBIN
INHIBITORS
WARFARIN
§ Inhibits fibrin clot formation
PLATELET
INHIBITORS
tPA
ASPIRIN
§ Inhibits platelet plug formation
© ETHICON, INC., 2006
CLOPIDOGREL
BISULFATE
§ Activates plasmin which
uPA
dissolves fibrin clot
13
Hemostasis & Sealing Market
TOPICAL ABSORBABLE HEMOSTATS
Traditional Hemostats
ADVANCED HEMOSTATS AND SEALANTS
Advanced Hemostats
COLLAGEN
ORC
GELATIN
FLOWABLE
THROMBIN
FIBRIN
SYN.SEALANT
INSTAT™
MCH
Microfibrillar
Collagen
Hemostat
SURGICEL®
Family of
Absorbable
Hemostats
SURGIFOAM™
Family of
Absorbable
Hemostats
SURGIFLO®
Hemostatic
Matrix
EVITHROM™
Thrombin,
Topical
(Human)
EVICELTM
Fibrin
Sealant
(Human)
ETHICON
OMNEX™
Surgical
Sealant
(In Europe
Only)
Gelfoam®
PFIZER/BAXTER
FloSeal® HT
BAXTER
Thrombin-JMI®
KING PHARMA
&
Recothrom®
ZYMOGENETICS
TISSEEL®
BAXTER
Avitene®
DAVOL
CoSeal®
BAXTER
BioGlue®
CRYOLIFE
DuraSeal®
TYCO
Oxidized Regenerated Cellulose (ORC)
COMPOSITION
Plant-derived Oxidized
Regenerated Cellulose
(ORC) available in various
fabric type formats
ADVANTAGES
• Multiple application
formats: open mesh, heavy
knit, fibrillar
• Plant-derived
• Minimal tissue reaction
• Bactericidal
MODE OF ACTION
• Absorbs fluid
• Causes vasoconstriction
• Aids in platelet plug formation
DISADVANTAGES
• Swelling can cause
pressure on adjacent
structures
• Impairs bone healing
Surgicel
Material Characteristics
3 formats: open weave, tight-knit and
non-woven
Absorbable in 7-14 days
Low pH creates bactericidal
environment
Plant based
How Does SURGICEL Work?
Oxidized Regenerated Cellulose (ORC) absorbs blood and becomes a gel
covering the site of vessel injury
It creates an area of low pH causing localized vasoconstriction
It then provides a matrix for platelet adhesion, accelerating the formation
of the platelet plug that will form the foundation of the fibrin clot
Why is SURGICEL Bactericidal?
Contact with moisture triggers the breakdown of cellulose and the
release of cellulosic acid
This causes a localized area of low pH (3.4-3.7)
Under acidic conditions, bacteria become less active
This pH lowering effect remains until the material is fully absorbed
in 7-14 days
SURGICEL : Features and Benefits
FEATURES
BENEFITS
Multiple Formats for
Various Applications
Open mesh
Heavy knit
Fibrillar
Superior Handling
Characteristics
Conforms to wound site
Won’t stick to gloves or instruments
Effective Hemostasis
Classic 6-8 min
SURGICEL NU-KNIT 3-5 min
SURGICEL FIBRILLAR 3-4 min
Plant-Based Material
No immunogenicity potential
Bactericidal
Inhibits growth of pathogenic organisms
Rapid Absorption
•Absorbed within 2 weeks (Absorption depends upon several
factors including the amount used, degree of saturation with blood, and the tissue bed)
SURGICEL FIBRILLAR
• Soft, layered, cotton-like fleece
• Can be applied in layers, tufts,
peanuts, rolls
• Conforms to irregular surfaces and
hard-to-reach places
• Adheres to the required region and
not to gloves or instruments
SURGICEL NU-KNIT
•
•
•
•
•
Thick, tightly-woven knit
Strong and flexible
Holds suture
Excellent for wrapping, bolsters
3X density of classic for greater
fluid absorption
Endoscopic Use
• Cut hemostat to desired size
• Grasp and pull until hemostat is enclosed at the end of the laparoscope
• Insert laparoscope into patient via the sleeve and reposition the scope
• Push hemostat into the cavity
• Using grasping instruments in auxiliary site, place hemostat
Endoscopic Use
Surgicel can be used to make bolsters in partial nephrectomy surgery
Hemostasis & Sealing Market
TOPICAL ABSORBABLE HEMOSTATS
Traditional Hemostats
ADVANCED HEMOSTATS AND SEALANTS
Advanced Hemostats
COLLAGEN
ORC
GELATIN
FLOWABLE
THROMBIN
FIBRIN
SYN.SEALANT
INSTAT™
MCH
Microfibrillar
Collagen
Hemostat
SURGICEL®
Family of
Absorbable
Hemostats
SURGIFOAM™
Family of
Absorbable
Hemostats
SURGIFLO®
Hemostatic
Matrix
EVITHROM™
Thrombin,
Topical
(Human)
EVICELTM
Fibrin
Sealant
(Human)
ETHICON
OMNEX™
Surgical
Sealant
(In Europe
Only)
Gelfoam®
PFIZER/BAXTER
FloSeal® HT
BAXTER
Thrombin-JMI®
KING PHARMA
&
Recothrom®
ZYMOGENETICS
TISSEEL®
BAXTER
Avitene®
DAVOL
CoSeal®
BAXTER
BioGlue®
CRYOLIFE
DuraSeal®
TYCO
SURGIFOAM/GELFOAM Absorbable Gelatin
SURGIFOAM Absorbable Gelatin Sponge
GELFOAM Absorbable Gelatin Sponge
SURGIFOAM Absorbable Gelatin Powder
How Does SURGIFOAM Powder
Work?
SURGIFOAM Powder provides a matrix for
platelet adhesion and aggregation, accelerating
the formation of the platelet plug that will form
the foundation of the fibrin clot
SURGIFOAM POWDER: Features and Benefits
FEATURES
BENEFITS
Customized
Consistency
Amount of saline can be adjusted to create a thick
or thin paste
Superior Handling
Characteristics
Won’t stick to gloves, instruments, or gauze
Can be molded into any shape
Can Be Used to
Deliver Thrombin
Fast hemostasis
Minimal Tissue
Reaction
Minimal foreign body reaction
Rapid Absorption
Absorbed in 4–6 weeks
SURGIFOAM Powder
•
•
•
•
Mixes easily to form a spreadable paste
Consistency is customizable
Spread along rough or uneven surfaces
Can be delivered by hand, with instruments,
or expressed from a syringe to access hardto-reach places
• Not used in urological procedures with any
frequency
• Surgifoam/Gelfoam sponges used more
frequently
Hemostasis & Sealing Market
TOPICAL ABSORBABLE HEMOSTATS
Traditional Hemostats
ADVANCED HEMOSTATS AND SEALANTS
Advanced Hemostats
COLLAGEN
ORC
GELATIN
FLOWABLE
THROMBIN
FIBRIN
SYN.SEALANT
INSTAT™
MCH
Microfibrillar
Collagen
Hemostat
SURGICEL®
Family of
Absorbable
Hemostats
SURGIFOAM™
Family of
Absorbable
Hemostats
SURGIFLO®
Hemostatic
Matrix
EVITHROM™
Thrombin,
Topical
(Human)
EVICELTM
Fibrin
Sealant
(Human)
ETHICON
OMNEX™
Surgical
Sealant
(In Europe
Only)
Gelfoam®
PFIZER/BAXTER
FloSeal® HT
BAXTER
Thrombin-JMI®
KING PHARMA
&
Recothrom®
ZYMOGENETICS
TISSEEL®
BAXTER
Avitene®
DAVOL
CoSeal®
BAXTER
BioGlue®
CRYOLIFE
DuraSeal®
TYCO
Flowable Gelatin
COMPOSITION
Animal-derived gelatin
mixed with thrombin (or
saline) in a flowable
consistency
ADVANTAGES
• Rapid hemostasis
• Precise application
• Flowable
MODE OF ACTION
• Aids in platelet plug
formation by providing a
matrix for platelet adhesion
and aggregation
• Aids fibrin clot formation
DISADVANTAGES
• Allergenic potential
(when bovine thrombin
is used)
• Preparation time
• Cost
Flowable Gelatin
§ Mechanism of action
§ Material Characteristics
• Gelatin provides a matrix
• 75% more tissue contact
for platelet aggregation
• Thrombin aids in fibrin
clot formation
than traditional gelatin
sponge
• Absorbable in 4-8 weeks
• May swell approximately
19% as it absorbs fluid
Flowable Mechanism of Action
Flowable applied to the tissue surface at the base of
the lesion. Granules fill wound and conform to its
shape.
Flowable granules swell (water in serum) approximately
20% within 10 minutes of application and physically
restrict the flow of blood.
Blood percolates through spaces and is exposed to high
concentrations of thrombin.
Thrombin converts fibrinogen to fibrin polymer - forms
clot around the mechanically stable matrix provided by
the granules. Structural integrity of the gelatin-fibrin
matrix enables it to remain in place at the tissue surface.
SURGIFLO/FLOSEAL: Features and Benefits
FEATURES
BENEFITS
Customized
consistency
Versatile delivery
The amount of saline or thrombin can be
adjusted for a customized flowable consistency
Quick prep time
Mixing requires only 5 to 6 transfers
Less than 30 seconds
Superior tissue
contact
Covers 75% more surface area than
traditional collagen sponges to conform to
irregular surfaces
Carrier for thrombin
Fast hemostasis
Biocompatible
Minimal foreign body reaction
Rapid absorption
Absorbed in 4-6 weeks
Multiple tips allow access to hard-to-reach places
FLOWABLE GELATINS
• SURGIFLO
• Uses human thrombin
• Low risk of immune
reaction
• Prep time: 30 seconds
• Easy to use and prepare
• FLOSEAL
• Uses bovine thrombin
• Higher risk of immune
reaction
• Prep Time: 60 seconds
• Easy to use and prepare
Endoscopic Applicator
•
Indicated for the endoscopic
delivery of hemostatic agents
•
Smooth, easy expression of
product
•
Narrow cannula lumen for
accurate delivery of agent
•
Single expression delivers nearly
5 times more product than the
competition
•
Ideal for use with both flowable
products
Hemostasis & Sealing Market
TOPICAL ABSORBABLE HEMOSTATS
Traditional Hemostats
ADVANCED HEMOSTATS AND SEALANTS
Advanced Hemostats
COLLAGEN
ORC
GELATIN
FLOWABLE
THROMBIN
FIBRIN
SYN.SEALANT
INSTAT™
MCH
Microfibrillar
Collagen
Hemostat
SURGICEL®
Family of
Absorbable
Hemostats
SURGIFOAM™
Family of
Absorbable
Hemostats
SURGIFLO®
Hemostatic
Matrix
EVITHROM™
Thrombin,
Topical
(Human)
EVICELTM
Fibrin
Sealant
(Human)
ETHICON
OMNEX™
Surgical
Sealant
(In Europe
Only)
Gelfoam®
PFIZER/BAXTER
FloSeal® HT
BAXTER
Thrombin-JMI®
KING PHARMA
&
Recothrom®
ZYMOGENETICS
TISSEEL®
BAXTER
Avitene®
DAVOL
CoSeal®
BAXTER
BioGlue®
CRYOLIFE
DuraSeal®
TYCO
Thrombin
COMPOSITION
MODE OF ACTION
• Aids in fibrin clot
formation
Bovine-derived or human
thrombin available in a
freeze dried powder
DISADVANTAGES
ADVANTAGES
• Quick hemostasis
• Multiple application
techniques
• Maintains visualization
during application (as
stand alone agent)
• Easy to use out of vial
•
•
•
•
Allergenic potential
Cost
Immunogenicity
Potential for
immunologically
mediated coagulopathy
Topical Thrombin
Mechanism of action
• Converts patient
fibrinogen to fibrin
Material Characteristics
• Lyophilized formats must be
mixed prior to use
• Liquid versions must be
refrigerated
• Immunogenic potential is high
with bovine thrombin
• Theoretical potential risk of
viral transmission exists with
Human Thrombin
Topical Thrombin – The Options
Bovine - purified from pooled bovine plasma1
• Not 100% homologous with human thrombin
• Contains bovine factor V
• Bovine thrombin and bovine factor V contain carbohydrate
groups that are inherently immunogenic in humans.
Recombinant Human – made in cell culture2
• Human prothrombin gene is spliced into Chinese hamster
ovary (CHO) cells
• CHO cells make human prothrombin and secrete it into cell culture
• Prothrombin is isolated and activated with a snake venom
enzyme (cleaves prothrombin into thrombin)
Human - purified from pooled human plasma
1. Lawson JH. The clinical use and immunologic impact of thrombin in surgery. Semin Thromb Hemost. 2006 ;Apr;32 Suppl 1:98-110.
2. Bishop PD, Lewis KB, Schultz J, Walker KM. Comparison of recombinant human thrombin and plasma-derived human alpha-thrombin.
Semin Thromb Hemost. 2006; Apr;32 Suppl 1:86-97.
40
What is Topical Bovine Thrombin?
Bovine Thrombin Preparations
• Are used in a variety of surgical procedures
including, but not limited to:
–
–
–
–
–
–
Cardiovascular Surgery
Vascular Surgery
Neurologic Surgery
Orthopaedic Surgery
General Surgery
Gynocological Surgery
• Estimated that more than 500,000 Americans are
exposed each year
Isolation of anti-Bovine Thrombin Antibodies
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
1989 90
91
92
93
94
95
96
YEAR
97
98
99
00
01
Immunologic Impact and Clinical Outcomes
Following Surgical Exposure to Bovine Thrombin
Thomas Ortel, Meg Mercer, Elizabeth Thames, Karen
Moore, and Jeffrey H. Lawson
Duke University Medical Center
Durham, NC
“Important Drug Warning”
“That patients who
have antibodies
against any of the
proteins found in
these drugs should
not be exposed to
these products.”
“The use of topical
bovine thrombin
preparations has
occasionally been
associated with
abnormalities in
hemostasis…”
Pooled Human Plasma Products1
§ The primary risk is pathogen transmission
§ In 1977, FDA banned all comercially prepared human
fibrinogen preparations because of the high rate of disease
transmission (HBV)
§ In 1998, FDA lifted this ban due to improved methods for
plasma protein purification
1. Guidance for Industry: Efficacy studies to support marketing of fibrin sealant products manufactured for
commercial use. CBER. May 1999.
Topical Thrombin
•Use either human or bovine proteins
•Equivalent time-to-hemostasis for human or bovine
thrombin
•Ready to use right out of the vial
•Needle-free prep, no mixing required
•Available in 2 mL, 5 mL, and 20 mL
•Products: Evithrom, Thrombin-JMI, Recothrom
•Used rarely in urological surgery
Hemostasis & Sealing Market
TOPICAL ABSORBABLE HEMOSTATS
Traditional Hemostats
ADVANCED HEMOSTATS AND SEALANTS
Advanced Hemostats
COLLAGEN
ORC
GELATIN
FLOWABLE
THROMBIN
FIBRIN
SYN.SEALANT
INSTAT™
MCH
Microfibrillar
Collagen
Hemostat
SURGICEL®
Family of
Absorbable
Hemostats
SURGIFOAM™
Family of
Absorbable
Hemostats
SURGIFLO®
Hemostatic
Matrix
EVITHROM™
Thrombin,
Topical
(Human)
EVICELTM
Fibrin
Sealant
(Human)
ETHICON
OMNEX™
Surgical
Sealant
(In Europe
Only)
Gelfoam®
PFIZER/BAXTER
FloSeal® HT
BAXTER
Thrombin-JMI®
KING PHARMA
&
Recothrom®
ZYMOGENETICS
TISSEEL®
BAXTER
Avitene®
DAVOL
CoSeal®
BAXTER
BioGlue®
CRYOLIFE
DuraSeal®
TYCO
The History of Fibrin Sealants
• 1909 - The use of fibrin to facilitate hemostasis was reported for the
first time (Bergel S. Uber Wirkungen des fibrins. Dtschr Med
Wochenschr. 1909;35:633-665.)
• 1944 - Plasma-derived fibrinogen and thrombin were used to
enhance the adherence of skin grafts (Cronkite EP, Lozner EL, Deaver
J Use of thrombin and fibrinogen in skin grafting. JAMA
1944;124:976-978.)
• 1972 - Highly concentrated fibrinogen made from frozen plasma
was used in to perform nerve anastomoses (Matras H, Dinges HP,
Mamoli B, Lassman H. Non-sutured nerve transplantation. J Maxillofac
Surg. 1973;1:37.)
The History of Fibrin Sealants
• 1975 - The first reports of clinical applications of autologous fibrin
sealant were published in Europe (Spangler H, Holle J, Moritz E et al.
Experimentelle Untersuchungen und erste klinische Erfahrungen uber
die totale Blutstillung mittels hochkonzentriertem Fibrin. Osterr Ges
Chir. 1975:605-610.)
• 1981 - The first fibrin sealant consisting of human thrombin and
highly concentrated human fibrinogen with enriched factor XIII
(fibrin stabilizing factor) was introduced in Europe (Brands W, Beck
M, Raute-Kriensen U. Gewebeklebung der ruptierten Milz mit
hochkonzentrientem Human-Fibrinogen. Z Kinderchir.
1981:32:341-348.)
Final Steps of Coagulation Cascade
Thrombin
Fibrinogen
Factor XIII
Fibrin monomer
Soluble fibrin polymer
Ca++
Factor XIIIa
Cross-linked insoluble fibrin polymer
Fibrin degradation products
www.emc.maricopa.edu/faculty/farabee/BIOBK/92756a.jpg.
Biologics – Thrombin & Fibrinogen
Can be stored at -18°C for 2 years, or refrigerated at 4°C for 30 days
Can be thawed at room temperature or in 37°C water bath in 10 minutes
Anti-Fibrinolytics in Fibrin
Sealants
• Anti-fibrinolytics inhibit the formation of plasmin from
plasminogen
• Plasmin breaks down the fibrin clot
• Tisseel contains aprotinin, an anti-fibrinolytic
• Plasminogen has been removed from Evicel through an
extra step in the manufacturing process
• It therefore does not need an anti-fibrinolytic agent to
prevent the formation of plasmin and subsequent
breakdown of the fibrin clot
53
US Indications by Brand
Product
EVICEL
TISSEEL
Indication Statements
• Adjunct to hemostasis for use in patients undergoing surgery,
when control of bleeding by standard surgical techniques is
ineffective or impractical.
• HEMOSTASIS: TISSEEL is indicated for use as an adjunct
to hemostasis in surgeries involving cardiopulmonary bypass
and treatment of splenic injuries due to blunt or penetrating
trauma to the abdomen, when control of bleeding by
conventional surgical techniques, including suture, ligature,
and cautery, is ineffective or impractical. TISSEEL is a
satisfactory hemostasis agent in fully heparinized patients
undergoing cardiopulmonary bypass.
• SEALING: TISSEEL has been shown to be an effective
sealant as an adjunct in the closure of colostomies.
FIBRIN SEALANTS
• EVICEL
• Uses human thrombin
(all human components)
• Low risk of immune
reaction
• No aprotinin or
tansexamanic acid
• Prep time: < 1 minute
• Easy to use and prepare
• Clear clot
• Rapidly absorbed
• Spray or drip
• TISSEEL
• Uses bovine thrombin
• Higher risk of immune
reaction
• Contains aprotinin
• Prep Time: 15 minutes
• Easy to use and prepare
• Cloudy white clot
• Rapidly absorbed
• Spray or drip
TISSEAL (Baxter)
Applicator Device
Pressure Regulator for Spray
Application
Fibrin Sealant
• Not indicated for the treatment of severe or brisk arterial bleeding.
• Contraindicated in individuals known to have anaphylactic or severe
systemic reaction to human blood products or bovine thrombin.
• Because some fibrin sealants are made from human plasma it may
carry a risk of transmitting infectious agents, such as viruses, and
theoretically, the Creutzfeldt-Jakob (CJD) agent.
• Anaphylactic reactions may occur.
• Do not inject fibrin sealants directly into the circulatory system or
tissue.
Instructions for Use
•
•
•
•
•
•
•
Use standard surgical techniques to control bleeding
Remove excess blood
A completely dry field is not mandatory
Apply sealant with the supplied application device
Spray or drip a thin, even layer
Apply second layer if the hemostatic effect is incomplete
Suture or cautery any bleeding point through the layer of
sealant (bleeders are easily visible, since the sealant is
transparent)
Clot Longevity Comparison*
Hemostasis & Sealing Market
TOPICAL ABSORBABLE HEMOSTATS
Traditional Hemostats
ADVANCED HEMOSTATS AND SEALANTS
Advanced Hemostats
COLLAGEN
ORC
GELATIN
FLOWABLE
THROMBIN
FIBRIN
INSTAT™
MCH
Microfibrillar
Collagen
Hemostat
SURGICEL®
Family of
Absorbable
Hemostats
SURGIFOAM™
Family of
Absorbable
Hemostats
SURGIFLO®
Hemostatic
Matrix
EVITHROM™
Thrombin,
Topical
(Human)
EVICELTM
Fibrin
Sealant
(Human)
Gelfoam®
PFIZER/BAXTER
FloSeal® HT
BAXTER
Thrombin-JMI®
KING PHARMA
&
Recothrom®
ZYMOGENETICS
TISSEEL®
BAXTER
Avitene®
DAVOL
SYN.SEALANT
ETHICON
OMNEX™
Surgical
Sealant
(In Europe
Only)
CoSeal®
BAXTER
BioGlue®
CRYOLIFE
DuraSeal®
TYCO
Synthetic Sealants
• Co-Seal and Bioglue most commonly used
products
• Creates a “shell” over area applied
• Not used in urological surgery; more common
in vascular surgery
BioGlue® (Cryolife Inc., Kennesaw, GA)
Composed of glutaraldehyde and purified
bovine serum albumin (BSA)
Binds covalently to tissue surface
Covalent bonds
N
Albumin
N
N
N
Glutaraldehyde
ECM / cell
surface
Crosseal® (OMRIX Biopharmaceuticals, Ltd.,
Belgium)
Mixture of human thrombin and fibrinogen
Terminal products of clotting cascade form solid
fibrin matrix
Thrombin
Fibrinogen
Fibrin monomer
Fibrin polymer