Haemostasis in Spine Surgery with

FLOSEAL Hemostatic Matrix

Fibrin Sealants

capillary/oozing arterial/spurting

Degree of Bleeding HeavyLight

*Gelatin and cellulose do not contain thrombin.

Gelatin and Cellulose*

IFU Comparison3-9

A Unique Combination

FLOSEAL Hemostatic Matrix’s patented gelatin granules and human thrombin provide fast and effective hemostasis.1,2

• Specially designed round-shaped patented gelatin granules allow for a large contact surface with thrombin for fast efficacy.

• Thrombin converts fibrinogen into a stable fibrin clot2

• Works at the beginning and the end of the clotting cascade, for action less susceptible to coagulopathies from factor deficiencies or platelet dysfunctions2

FLOSEAL Patented Granules Mechanically Stable Clot

The FLOSEAL Hemostatic Matrix Advantage

Benefits of FLOSEAL Hemostatic Matrix for Spine Surgery

• Stops bleeding fast in 90 seconds (median time to haemostasis)1

• Improves visualization and speeds up re-access to the surgical field1,10

• Helps protect against rebleeding by forming a mechanically stable clot2

• Effective on bone bleeding and can be applied to blood submerged sites4

• Proven 89% effective in heparinized patients within 10 minutes3

Haemostasis achieved with FLOSEAL with a single application in a laminectomy procedure.

FLOSEAL Hemostatic Matrix Application

FLOSEAL may be used in any spine procedure where there is active bleeding.

Potential active bleeding sites include:

• Cut bone surfaces

– Intervertebral foramina

– Vertebral body subchondral bone

• Paravertebral musculature

• Pilot hole oozing

• Epidural and venous plexus oozing

• Facet decalcified surfaces

• Cut laminar surfaces

Several applicator tips are available to make FLOSEAL application easier in difficult-to-reach locations.

Malleable Tip

Trimmable Tip

FLOSEAL may be used on punctuate bleeding from the cortical bone

1

After FLOSEAL is applied to the bleeding surface, gently approximate a moistened gauze or cottonoid pledget for approximately 2 minutes to maintain product on site at the time of fibrin polymerization

2

Once haemostasis is achieved, gently irrigate any excess FLOSEAL that has not been incorporated into the clot

3

FLOSEAL Hemostatic Matrix Application*Standard lumbar spine laminectomy, and posterior lumbar interbody fusion

*For the instructions of the preparation of the thrombin solution, please consult your IFU.

FLOSEAL may be used for bleeding from the cancellous bone surfaces

1

After FLOSEAL is applied to the bleeding surface, gently approximate a moistened gauze or cottonoid pledget for approximately 2 minutes to maintain product on site at the time of fibrin polymerization

2

Once haemostasis is achieved, gently irrigate any excess FLOSEAL Hemostatic Matrix that has not been incorporated into the clot

3

FLOSEAL Hemostatic Matrix ApplicationStandard lumbar spine laminectomy, and posterior lumbar interbody fusion

FLOSEAL may be used for bleeding from the epidural veins, after the nerve root is retracted to expose disc space in order to perform the discectomy

1

After FLOSEAL is applied to the bleeding surface, gently approximate a moistened gauze or cottonoid pledget for approximately 2 minutes to maintain product on site at the time of fibrin polymerization

2

Once haemostasis is achieved, gently irrigate any excess FLOSEAL Hemostatic Matrix that has not been incorporated into the clot

3

FLOSEAL may be used for bone bleeding from the interspace, prior to performing posterior lumbar interbody fusion, and once the discectomy is performed

1

After FLOSEAL is applied to the bleeding surface, gently approximate a moistened gauze or cottonoid pledget for approximately 2 minutes to maintain product on site at the time of fibrin polymerization

2

Once haemostasis is achieved, gently irrigate any excess FLOSEAL Hemostatic Matrix that has not been incorporated into the clot

3

FLOSEAL Hemostatic Matrix ApplicationStandard lumbar spine laminectomy, and posterior lumbar interbody fusion

Tips for Application4

Swoosh

Place

Approximate

Rinse and Continue

Transfer the gelatin matrix-thrombin solution mixture back and forth between the syringes for a total of at least twenty passes.

Identify the source of bleeding at the tissue surface. This is the target site for FLOSEAL Matrix application. Do not inject FLOSEAL Matrix into blood vessels.

Manually approximate a gauze sponge moistened with sterile (non-heparinized) saline against the bleeding surface. Use the applicator tip to dispense FLOSEAL between the sponge and the bleeding surface.

After approximately two minutes, lift the gauze sponge and inspect the wound site.

If bleeding has ceased, excess FLOSEAL Matrix (not incorporated in the haemostatic clot) should be removed by gentle irrigation. FLOSEAL may be reapplied if necessary to control bleeding.

1

2

3

4

1. Can FLOSEAL Hemostatic Matrix be used on bony areas that will be fused? FLOSEAL is effective on all types of bleeding from oozing to spurting. Enough blood needs to be present for FLOSEAL to work, as it needs to interact with patient’s fibrinogen and platelets to be activated. Excess FLOSEAL (material not incorporated in the haemostatic clot) should be removed by gentle irrigation from the site of application, particularly when used in, around, or in proximity to foramina in bone, confined bony areas on the spinal cord, and/or the optic nerve and chiasm.3

2. Can FLOSEAL Hemostatic Matrix be used around nerves/dura? Yes. FLOSEAL has been used in various types of cervical and lumbar procedures.1 When placed into cavities or closed tissue spaces, gentle approximation is advised. When applied to a bleeding site, the particles of FLOSEAL Matrix swell approximately 20% upon contact with blood or other fluids. Maximum swell volume is achieved within about 10 minutes.4

3. Does FLOSEAL Hemostatic Matrix seal the dura or dural tears? No. FLOSEAL should not be used to seal dural tears. FLOSEAL acts as a haemostat only, and is not a sealant.

Frequently Asked Questions

References 1. Renkens KL Jr., Payner TD, Leipzig TJ, et al. A multicenter, prospective,

randomized trial evaluating a new hemostatic agent for spinal surgery. Spine. 2001;26:1645-1650.

2. Oz MC, Rondinone JF, Shargill NS. Floseal matrix: new generation topical hemostatic sealant. J Card Surg. 2003;18:486-493.

3. Oz MC, Cosgrove DM, Badduke BR. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg. 2000; 69: 1376-138

4. Floseal VH S/D Hemostatic Matrix [instructions for use]. Zurich, Switzerland: Baxter Healthcare SA; 2009.

5. Avitene [Instructions For Use]. Murray Hill, NJ: CR Bard Inc; 2002. 6. Gelfoam [Instructions For Use]. Kalamazoo, MI: Pharmacia & Upjohn

Co; 2003. 7. Surgicel, Surgicel Fibrillar, and Surgicel Nu-Knit Absorbable Hemostats

[full prescribing information]. Somerville, NJ: Ethicon Inc; 2005. 8. Surgifoam [essential prescribing information]. Somerville, NJ:

Ethicon Inc; 2004. 9. Tisseel VH S/D Fibrin Sealant [Instructions For Use]. Zurich,

Switzerland: Baxter Healthcare SA; 2009.10. Stoltze D, Harms J. The use of fibrin sealants in spinal surgery. In:

Haemostasis in Spine Surgery. Szpalski M, Gunzburg R, Weiskopf RB, Aebi M, eds. New York, NY: Springer-Verlag; 2005:97-102.

11. US IMS data. 2008.12. EU Market Research. Baxter International Inc; July 2008.13. F&S Report: M2F8-54. Oct 2008.

FLOSEAL [Hemostatic Matrix] IndicationsFLOSEAL is indicated in invasive*1 or surgically invasive*2 procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.*1 Invasive means penetration inside the body through a body orifice*2 Surgically invasive means penetration inside the body through

the surface of the body, with the aid or in the context of a surgical operation

ContraindicationsDo not use FLOSEAL in patients with known allergies to materials of bovine origin.

WarningsDo not inject or compress FLOSEAL into blood vessels. For a complete list of all warnings please refer to your IFU.

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Quantity Code Description Packaging

________ 1501510 Floseal Hemostatic Matrix 5 ml 6 pack________ 1500181 endoscopic applicator Tip 6 pack________ 934208 Curved applicator Tip 8 cm single pack________ 934210 Curved applicator Tip 10 cm single pack________ 1502186 Malleable/Trimmable Tips 6 pack

surgeon name (please print)

signature Date

11-1311-13

Baxter Healthcare SA P.O. Box CH-8010 Zurich Switzerland

www.baxterbiosurgery.com

Baxter, Floseal, and Advancing Surgery, Enhancing Life are trademarks of Baxter International Inc., its subsidiaries or affiliates.BS-BS-444 June 2010