BioSurgery Advancing Surgery, Enhancing Life

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Rapid Hemostasis

FLOSEAL Hemostatic Matrix is a proprietary combination of cross-linked gelatin granules and topical human thrombin.

Stops bleeding in 2 minutes or less (median time to hemostasis)1

Consistent and Effective Hemostasis1

Consistent and Effective Hemostasis

  • Stops bleeding 97% of the time within 6-10 minutes [per protocol analysis]1
  • Proven to control bleeding from oozing to pulsatile flow1
  • Effective 89% of the time within 10 minutes in heparinized cardiac patients1
  • Effective on both hard and soft tissue2
  • Swells only 20% within 10 minutes1

Easy to Use

  • Works on wet, actively bleeding tissue and conforms to irregular wound surfaces3
  • Convenient kit contains all the items necessary for use, including human thrombin, and can be prepared in as short as 2 minutes
  • FLOSEAL can be applied focally or extruded and spread to cover a large area of diffuse bleeding*

*Please refer to the Instructions For Use for complete application techniques

Consequences of Surgical Bleeding


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The Human Thrombin Advantage

Differences in the molecular structure between bovine thrombin and human thrombin exist.10,11,12,13 Bovine thrombin is recognized as foreign by the human immune system and may illicit an immune response4,5,6

The use of bovine thrombin in surgery has been shown to cause antibody formation which cross-reacts to the patient's own thrombin and other coagulation factors such as Factor V. This has lead to complex post surgical coagulopathies. 5,7 Human antibodies are less likely to cross react with human thrombin than with bovine thrombin.4

Thrombin is made from pooled human plasma.  The two-step vapor heat treatment used in its manufacture has been shown to be capable of significant viral reduction.  However, no procedure has been shown to be completely effective in removing viral infectivity from derivatives of human plasma (See Warnings).1

Commercially Available Human Thrombin12, 13

Human Thrombin

Commercially Available Bovine Thrombin10,11

Bovine Thrombin

  • By design, FLOSEAL containing human thrombin at 500 IU/mL exhibits equal effectiveness as FLOSEAL containing bovine thrombin at 1000 IU/mL.8
  • Biocompatible and all matrix incorporated into the clot may be left in situ.1

Safety Profile

  • Bio-resorbable9
  • Biocompatible/pH neutral9
  • Latex free

FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

FLOSEAL Instructions For Use

Important FLOSEAL Safety Information

Order Information

Order # Description
1501285 FLOSEAL [Hemostatic Matrix] 10 mL, 6 pack
934057 FLOSEAL [Hemostatic Matrix], 5 mL, 6 pack
934050 FLOSEAL NT [Hemostatic Matrix], 5 mL, 6 pack
934208 Curved Applicator Tip, 8cm
934210 Curved Applicator Tip, 10cm
934055 FLOSEAL Endoscopic Applicator (Reusable)
1500181 FLOSEAL Endoscopic Applicator, 6 pack

References
  1. FLOSEAL [Hemostatic Matrix] Instructions for Use, 0706463.
  2. Renkens Jr K.L., et al. A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine 2001; 26:1645-1650.
  3. Oz M.C., Cosgrove D.M., Badduke B.R., et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thoracic Surgery, 69(5): 1376-82, 2000.
  4. Schoenecker JG, Hauck RK, Mercer MC, et al. Exposure to topical bovine thrombin during surgery elicits a response against the xenogeneic carbohydrate galactose alpha1-3galactose. J Clin Immunol. 2000 Nov;20(6):434-44.
  5. Ortel TL, Mercer MC, Thames EH, et al. "Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin." Ann Surg 2001; 233: 88-96.
  6. Lawson J.H., "The clinical use and immunologic impact of thrombin in surgery." Seminars in Thrombosis and Hemostasis. 2006 Apr;32 Suppl 1:98-110.
  7. Rapaport SI, Zivelin A, Minow RA, et al. "Clinical significance of antibodies to bovine and human thrombin and factor V after surgical use of bovine thrombin." Am J Clin Pathol 1992; 97; 84-91.
  8. Data on file. Baxter Healthcare Corporation.
  9. Cheung C, Vega, Taw J, Reich, CD, Shargill NS. FLOSEAL Matrix Hemostatic Sealant safety, toxicology and biocompatibility studies. Baxter Technical Bulletin, Rev 02-009, 2002.
  10. Engh R.A. et al., Enzyme flexibility, solvent and 'weak' interactions characterize thrombin-ligand interactions: implications for drug design. Structure v4 pp.1353-1362, 1996.
  11. http://www.rcsb.org/pdb/explore/expore.do?structureId=IUVU">http://www.rcsb.org/pdb/explore/expore.do?structureId=IUVU.
  12. Johnson DJD, et al. Crystal structure of wild-type human in the Na+-free state. Biochem J. v392 pp.21-29, 2005.
  13. http://www.rcsb.org/pdb/explore.dp?structureId+2AFQ">http://www.rcsb.org/pdb/explore.dp?structureId+2AFQ.
  14. Mehmet Oz, et al. Floseal Matrix: New Generation Topical Hemostatic Sealant. J Card Surg. 18 (2003): 486-493.