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Keyline for Dieline Only-Do Not Print
934057 FLOSEAL Hemostatic Matrix, 5 mL, 6 pack
934208 Curved Applicator Tip, 8 cm
934210 Curved Applicator Tip, 10 cm
1500181 FLOSEAL Endoscopic Applicator. 6 pack
Mechanism of Action: Biophysical Hemostasis2
Stop Bleeding
Surgical Examples
FLOSEAL [Hemostatic Matrix] Indications
Cardiac
1
2
Bleeding in anostomotic site
FLOSEAL application
Contraindications
Do not inject or compress FLOSEAL into blood vessels. Do not apply FLOSEAL to
clamped or bypassed vessels. Extensive intravascular clotting and even death may result.
Do not use FLOSEAL in patients with known allergies to materials of bovine origin.
FLOSEAL granules expand approximately 20%
within 10 minutes and physically restrict the
flow of blood. Blood percolates through the
spaces and is exposed to thrombin.
Warnings
FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper
application of ligatures or other conventional procedures for hemostasis. FLOSEAL is effective
on surgical bleeding, from oozing to active and is not intended to be used as a prophylactic
hemostatic agent.
After FLOSEAL application
Vascular
Bleeding from PTFE
needle holes
FLOSEAL is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding
by ligature or conventional procedures is ineffective or impractical.
FLOSEAL Hemostatic Matrix is applied to
the tissue surface at the base of the lesion. Its
granules fill the wound and conform to its shape.
3
A clot forms around the mechanically stable
matrix provided by the granules. The structural
integrity of the gelatin fibrin matrix enables it
to remain in place at the tissue surface.
4
FLOSEAL granules not incorporated in
the clot can and should be removed with
gentle irrigation without disrupting the
hemostatic seal.
As with any implantable material, the use of FLOSEAL is not recommended in the presence of an
active infection.
www.floseal.com
www.baxterbiosurgery.com
References
After FLOSEAL application
5
FLOSEAL is resorbed by the body within 6–8
weeks, consistent with the time frame of
normal wound healing.
1. Renkens Jr K.L. et al. A Multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine 2001; 26:1645-1650.
2. Oz, M.C., Rondinone, J.F., and Shargill, N.S. FLOSEAL matrix: New generation topical hemostatic sealant J Card Surg Nov., 2003 (18) 6:486-493.
3. Oz MC, Cosgrove DM, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surgery, 69(5): 1376-82, 2000
4. Fiss I, Danne M, Stendel R. use of gelatin-thrombin matrix hemostatic sealant in cranial neurosurgery. Neurol Med Chir 47,462-467,2007.
5. FLOSEAL Hemostatic Matrix Indications for Use, US, 03/2005
6. FLOSEAL Hemostatic Matrix, Instructions for Use, Europe, 08/06
0123
When you have to work fast, FLOSEAL works at the speed you do because
FLOSEAL stops bleeding in 2 minutes (median time to hemostasis).2,5
BAXTER, FLOSEAL and ADVANCING SURGERY, ENHANCING LIFE
are trademarks of Baxter International Inc.
BS-BS-156 June 2008
Baxter Healthcare S.A.
Hertistrasse 2
CH-8304 Wallisellen
FAST
2
Keyline for Dieline Only-Do Not Print
Stop Bleeding
FAST
Haemostatic Agents in the Coagulation Cascade
2
Rapid, Effective, Consistent...
• Stops bleeding in 2 minutes (median time to hemostasis)2,5
CONTACT
ACTIVATION
• Stops bleeding 96% of the time within 10 minutes2
TISSUE
DAMAGE
• Proven to control bleeding from oozing to pulsatile flow2
Collagen, cellulose and
gelatin start activation here
• Effective among hepranized patients3
INTRINSIC
PATHWAY
PLATELETS
EXTRINSIC
PATHWAY
Easy to Handle and Use
Collagen, cellulose and gelatin have
limited haemostatic effect on heparinized
patients or if platelet function is
compromised by drugs or other means.
ACTIVATED
PLATELETS
• Works on wet, actively bleeding tissue and conforms to irregular wound surfaces3,6
• FLOSEAL Hemostatic Matrix can be applied to both hard and soft tissue1
PROTHROMBIN
Consequences of
Surgical Bleeding
THROMBIN
FIBRINOGEN
• Prolonged Operating Time
• Floseal can be applied focally or dispensed and spread to cover a large area
of diffuse bleeding1
FIBRIN
MONOMER
FIBRIN
POLYMER
FIBRIN
CLOT
• Convenient kit contains all items necessary for use, including bovine thrombin,
and can be prepared in 60 seconds4
BY PROVIDING THROMBIN,
FLOSEAL STARTS ACTIVATION also HERE
• Risk of Transfusion
Controlled Prospective Clinical Trial2,5
• Patient Complications
N=309; Cardiovascular/Vascular/Spinal-Orthopedic Surgery
• Decreased Visibility
309 patients were randomized after bleeding was identified to FLOSEAL or bovine thrombin soaked gelatin sponge
(Control) groups. Success was defined as hemostasis within 10 minutes and bleeding was checked at 1, 2, 3, 6 and 10
minutes.3 Bleeding was rated as “oozing,“ “flowing” or “pulsatile,” with approximately one-third of the patients falling
into the latter two categories.
cumulative cost
Treatment of Surgical Bleeding (Illustrative)
clips suture
ligature
FLOSEAL*
HEMOSTATIC
matrix
platelets/
products
coagulation
factors/products
whole blood/
products
Percent Stopped Bleeding (First Lesion)†
other
measures
32%
21%
cautery
0-1
0-1 Minute
minute
1-2
1-2Minutes
minutes
*(62/153) (32/150)
*(106/153) (48/150)
FLOSEAL
*FLOSEAL Hemostatic Matrix applied here may prevent further consequences of surgical bleeding and helps
save time, operating costs, product consumption and reduce stress in OR.1
†Please refer to the Instructions For Use for complete application techniques.
68%
69%
41%
Time
†
per protocol analysis
97%
93%
85%
77%
48%
2-3
Minutes
2-3 minutes
*(130/153) (72/150)
3-6
3-6 Minutes
minutes
6-10
Minutes
6-10 minutes
*(143/153) (102/150)
*(149/153) (115/150)
Thrombin soaked gelatin sponge
*Cumulative Percent of Patients with Complete Hemostasis
Keyline for Dieline Only-Do Not Print
Stop Bleeding
FAST
Haemostatic Agents in the Coagulation Cascade
2
Rapid, Effective, Consistent...
• Stops bleeding in 2 minutes (median time to hemostasis)2,5
CONTACT
ACTIVATION
• Stops bleeding 96% of the time within 10 minutes2
TISSUE
DAMAGE
• Proven to control bleeding from oozing to pulsatile flow2
Collagen, cellulose and
gelatin start activation here
• Effective among hepranized patients3
INTRINSIC
PATHWAY
PLATELETS
EXTRINSIC
PATHWAY
Easy to Handle and Use
Collagen, cellulose and gelatin have
limited haemostatic effect on heparinized
patients or if platelet function is
compromised by drugs or other means.
ACTIVATED
PLATELETS
• Works on wet, actively bleeding tissue and conforms to irregular wound surfaces3,6
• FLOSEAL Hemostatic Matrix can be applied to both hard and soft tissue1
PROTHROMBIN
Consequences of
Surgical Bleeding
THROMBIN
FIBRINOGEN
• Prolonged Operating Time
• Floseal can be applied focally or dispensed and spread to cover a large area
of diffuse bleeding1
FIBRIN
MONOMER
FIBRIN
POLYMER
FIBRIN
CLOT
• Convenient kit contains all items necessary for use, including bovine thrombin,
and can be prepared in 60 seconds4
BY PROVIDING THROMBIN,
FLOSEAL STARTS ACTIVATION also HERE
• Risk of Transfusion
Controlled Prospective Clinical Trial2,5
• Patient Complications
N=309; Cardiovascular/Vascular/Spinal-Orthopedic Surgery
• Decreased Visibility
309 patients were randomized after bleeding was identified to FLOSEAL or bovine thrombin soaked gelatin sponge
(Control) groups. Success was defined as hemostasis within 10 minutes and bleeding was checked at 1, 2, 3, 6 and 10
minutes.3 Bleeding was rated as “oozing,“ “flowing” or “pulsatile,” with approximately one-third of the patients falling
into the latter two categories.
cumulative cost
Treatment of Surgical Bleeding (Illustrative)
clips suture
ligature
FLOSEAL*
HEMOSTATIC
matrix
platelets/
products
coagulation
factors/products
whole blood/
products
Percent Stopped Bleeding (First Lesion)†
other
measures
32%
21%
cautery
0-1
0-1 Minute
minute
1-2
1-2Minutes
minutes
*(62/153) (32/150)
*(106/153) (48/150)
FLOSEAL
*FLOSEAL Hemostatic Matrix applied here may prevent further consequences of surgical bleeding and helps
save time, operating costs, product consumption and reduce stress in OR.1
†Please refer to the Instructions For Use for complete application techniques.
68%
69%
41%
Time
†
per protocol analysis
97%
93%
85%
77%
48%
2-3
Minutes
2-3 minutes
*(130/153) (72/150)
3-6
3-6 Minutes
minutes
6-10
Minutes
6-10 minutes
*(143/153) (102/150)
*(149/153) (115/150)
Thrombin soaked gelatin sponge
*Cumulative Percent of Patients with Complete Hemostasis
Keyline for Dieline Only-Do Not Print
934057 FLOSEAL Hemostatic Matrix, 5 mL, 6 pack
934208 Curved Applicator Tip, 8 cm
934210 Curved Applicator Tip, 10 cm
1500181 FLOSEAL Endoscopic Applicator. 6 pack
Mechanism of Action: Biophysical Hemostasis2
Stop Bleeding
Surgical Examples
FLOSEAL [Hemostatic Matrix] Indications
Cardiac
1
2
Bleeding in anostomotic site
FLOSEAL application
Contraindications
Do not inject or compress FLOSEAL into blood vessels. Do not apply FLOSEAL to
clamped or bypassed vessels. Extensive intravascular clotting and even death may result.
Do not use FLOSEAL in patients with known allergies to materials of bovine origin.
FLOSEAL granules expand approximately 20%
within 10 minutes and physically restrict the
flow of blood. Blood percolates through the
spaces and is exposed to thrombin.
Warnings
FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper
application of ligatures or other conventional procedures for hemostasis. FLOSEAL is effective
on surgical bleeding, from oozing to active and is not intended to be used as a prophylactic
hemostatic agent.
After FLOSEAL application
Vascular
Bleeding from PTFE
needle holes
FLOSEAL is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding
by ligature or conventional procedures is ineffective or impractical.
FLOSEAL Hemostatic Matrix is applied to
the tissue surface at the base of the lesion. Its
granules fill the wound and conform to its shape.
3
A clot forms around the mechanically stable
matrix provided by the granules. The structural
integrity of the gelatin fibrin matrix enables it
to remain in place at the tissue surface.
4
FLOSEAL granules not incorporated in
the clot can and should be removed with
gentle irrigation without disrupting the
hemostatic seal.
As with any implantable material, the use of FLOSEAL is not recommended in the presence of an
active infection.
www.floseal.com
www.baxterbiosurgery.com
References
After FLOSEAL application
5
FLOSEAL is resorbed by the body within 6–8
weeks, consistent with the time frame of
normal wound healing.
1. Renkens Jr K.L. et al. A Multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine 2001; 26:1645-1650.
2. Oz, M.C., Rondinone, J.F., and Shargill, N.S. FLOSEAL matrix: New generation topical hemostatic sealant J Card Surg Nov., 2003 (18) 6:486-493.
3. Oz MC, Cosgrove DM, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surgery, 69(5): 1376-82, 2000
4. Fiss I, Danne M, Stendel R. use of gelatin-thrombin matrix hemostatic sealant in cranial neurosurgery. Neurol Med Chir 47,462-467,2007.
5. FLOSEAL Hemostatic Matrix Indications for Use, US, 03/2005
6. FLOSEAL Hemostatic Matrix, Instructions for Use, Europe, 08/06
0123
When you have to work fast, FLOSEAL works at the speed you do because
FLOSEAL stops bleeding in 2 minutes (median time to hemostasis).2,5
BAXTER, FLOSEAL and ADVANCING SURGERY, ENHANCING LIFE
are trademarks of Baxter International Inc.
BS-BS-156 June 2008
Baxter Healthcare S.A.
Hertistrasse 2
CH-8304 Wallisellen
FAST
2
Keyline for Dieline Only-Do Not Print
934057 FLOSEAL Hemostatic Matrix, 5 mL, 6 pack
934208 Curved Applicator Tip, 8 cm
934210 Curved Applicator Tip, 10 cm
1500181 FLOSEAL Endoscopic Applicator. 6 pack
Mechanism of Action: Biophysical Hemostasis2
Stop Bleeding
Surgical Examples
FLOSEAL [Hemostatic Matrix] Indications
Cardiac
1
2
Bleeding in anostomotic site
FLOSEAL application
Contraindications
Do not inject or compress FLOSEAL into blood vessels. Do not apply FLOSEAL to
clamped or bypassed vessels. Extensive intravascular clotting and even death may result.
Do not use FLOSEAL in patients with known allergies to materials of bovine origin.
FLOSEAL granules expand approximately 20%
within 10 minutes and physically restrict the
flow of blood. Blood percolates through the
spaces and is exposed to thrombin.
Warnings
FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper
application of ligatures or other conventional procedures for hemostasis. FLOSEAL is effective
on surgical bleeding, from oozing to active and is not intended to be used as a prophylactic
hemostatic agent.
After FLOSEAL application
Vascular
Bleeding from PTFE
needle holes
FLOSEAL is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding
by ligature or conventional procedures is ineffective or impractical.
FLOSEAL Hemostatic Matrix is applied to
the tissue surface at the base of the lesion. Its
granules fill the wound and conform to its shape.
3
A clot forms around the mechanically stable
matrix provided by the granules. The structural
integrity of the gelatin fibrin matrix enables it
to remain in place at the tissue surface.
4
FLOSEAL granules not incorporated in
the clot can and should be removed with
gentle irrigation without disrupting the
hemostatic seal.
As with any implantable material, the use of FLOSEAL is not recommended in the presence of an
active infection.
www.floseal.com
www.baxterbiosurgery.com
References
After FLOSEAL application
5
FLOSEAL is resorbed by the body within 6–8
weeks, consistent with the time frame of
normal wound healing.
1. Renkens Jr K.L. et al. A Multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine 2001; 26:1645-1650.
2. Oz, M.C., Rondinone, J.F., and Shargill, N.S. FLOSEAL matrix: New generation topical hemostatic sealant J Card Surg Nov., 2003 (18) 6:486-493.
3. Oz MC, Cosgrove DM, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surgery, 69(5): 1376-82, 2000
4. Fiss I, Danne M, Stendel R. use of gelatin-thrombin matrix hemostatic sealant in cranial neurosurgery. Neurol Med Chir 47,462-467,2007.
5. FLOSEAL Hemostatic Matrix Indications for Use, US, 03/2005
6. FLOSEAL Hemostatic Matrix, Instructions for Use, Europe, 08/06
0123
When you have to work fast, FLOSEAL works at the speed you do because
FLOSEAL stops bleeding in 2 minutes (median time to hemostasis).2,5
BAXTER, FLOSEAL and ADVANCING SURGERY, ENHANCING LIFE
are trademarks of Baxter International Inc.
BS-BS-156 June 2008
Baxter Healthcare S.A.
Hertistrasse 2
CH-8304 Wallisellen
FAST
2
Keyline for Dieline Only-Do Not Print
934057 FLOSEAL Hemostatic Matrix, 5 mL, 6 pack
934208 Curved Applicator Tip, 8 cm
934210 Curved Applicator Tip, 10 cm
1500181 FLOSEAL Endoscopic Applicator. 6 pack
Mechanism of Action: Biophysical Hemostasis2
Stop Bleeding
Surgical Examples
FLOSEAL [Hemostatic Matrix] Indications
Cardiac
1
2
Bleeding in anostomotic site
FLOSEAL application
Contraindications
Do not inject or compress FLOSEAL into blood vessels. Do not apply FLOSEAL to
clamped or bypassed vessels. Extensive intravascular clotting and even death may result.
Do not use FLOSEAL in patients with known allergies to materials of bovine origin.
FLOSEAL granules expand approximately 20%
within 10 minutes and physically restrict the
flow of blood. Blood percolates through the
spaces and is exposed to thrombin.
Warnings
FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper
application of ligatures or other conventional procedures for hemostasis. FLOSEAL is effective
on surgical bleeding, from oozing to active and is not intended to be used as a prophylactic
hemostatic agent.
After FLOSEAL application
Vascular
Bleeding from PTFE
needle holes
FLOSEAL is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding
by ligature or conventional procedures is ineffective or impractical.
FLOSEAL Hemostatic Matrix is applied to
the tissue surface at the base of the lesion. Its
granules fill the wound and conform to its shape.
3
A clot forms around the mechanically stable
matrix provided by the granules. The structural
integrity of the gelatin fibrin matrix enables it
to remain in place at the tissue surface.
4
FLOSEAL granules not incorporated in
the clot can and should be removed with
gentle irrigation without disrupting the
hemostatic seal.
As with any implantable material, the use of FLOSEAL is not recommended in the presence of an
active infection.
www.floseal.com
www.baxterbiosurgery.com
References
After FLOSEAL application
5
FLOSEAL is resorbed by the body within 6–8
weeks, consistent with the time frame of
normal wound healing.
1. Renkens Jr K.L. et al. A Multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine 2001; 26:1645-1650.
2. Oz, M.C., Rondinone, J.F., and Shargill, N.S. FLOSEAL matrix: New generation topical hemostatic sealant J Card Surg Nov., 2003 (18) 6:486-493.
3. Oz MC, Cosgrove DM, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surgery, 69(5): 1376-82, 2000
4. Fiss I, Danne M, Stendel R. use of gelatin-thrombin matrix hemostatic sealant in cranial neurosurgery. Neurol Med Chir 47,462-467,2007.
5. FLOSEAL Hemostatic Matrix Indications for Use, US, 03/2005
6. FLOSEAL Hemostatic Matrix, Instructions for Use, Europe, 08/06
0123
When you have to work fast, FLOSEAL works at the speed you do because
FLOSEAL stops bleeding in 2 minutes (median time to hemostasis).2,5
BAXTER, FLOSEAL and ADVANCING SURGERY, ENHANCING LIFE
are trademarks of Baxter International Inc.
BS-BS-156 August 2008
Baxter Healthcare S.A.
Hertistrasse 2
CH-8304 Wallisellen
FAST
2