FLOSEAL [Hemostatic Matrix]

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

• Works on wet, actively bleeding tissue and conforms to irregular wound surfaces ²
• Proven to control bleeding from oozing to pulsatile flow ¹
• 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  Instructions For Use for complete application techniques
• FLOSEAL can be applied to both hard and soft tissue ³

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

FLOSEAL must not be injected into blood vessels, or allowed to enter blood vessels. Do not apply in the absence of active bleeding. Extensive intravascular clotting and even death may result.
Do not use FLOSEAL in the closure of skin incisions because it may interfere with the healing of the skin edges.
Do not use FLOSEAL in patients with known allergies to materials of bovine origin.
FLOSEAL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
The maximum swell volume of approximately 20% is achieved within about 10 minutes. Excess FLOSEAL (material not incorporated in the hemostatic clot) should be removed from the site of application using gentle irrigation.
FLOSEAL should not be used in conjunction with methylmethacrylate or other acrylic adhesives.




RX Only: For safe and proper use of this device, please refer to full device Instructions For Use.

1. Floseal Hemostatic Matrix Instructions For Use, 03/2005.
2. 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.
3. Renkens Jr. K.L., et al.  A Multicenter, Prospective, Randomized Trial Evaluating a New Hemostatic Agent for Spinal Surgery.  Spine 2001: 26: 1645-1650.

FLOSEAL is a trademark of Baxter International Inc.