Surgery

FLOSEAL Hemostatic Matrix

FLOSEAL Hemostatic Matrix

Fast. Effective. Proven.

As a leader in hemostasis, Baxter is committed to providing innovative solutions for surgeons. FLOSEAL is an approved adjunct hemostatic agent proven effective in a wide-range of bleeding scenarios1 with a proprietary combination of two independent hemostatic agents.1, 2

  • Bleeding is stopped fast – 2 minutes median time1 and FLOSEAL stops bleeding within 10 minutes 96% of the time1
  • Works on active bleeding1

FLOSEAL Hemostatic Matrix Indication

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

Important Risk Information for FLOSEAL Matrix

Do not inject or compress FLOSEAL Matrix into blood vessels. Do not apply FLOSEAL Matrix in the absence of active blood flow, e.g., while the vessel is clamped or bypassed, as extensive intravascular clotting and even death may result.

Do not use FLOSEAL Matrix in patients with known allergies to materials of bovine origin. Do not use FLOSEAL Matrix in the closure of skin incisions because it may interfere with the healing of the skin edges.

FLOSEAL Matrix contains Thrombin 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 Matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.

Excess FLOSEAL Matrix (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation from the site of application.

FLOSEAL Matrix swells by approximately 10% to 20% after product is applied. Maximum swell volume is achieved within about 10 minutes.

The safety and effectiveness of FLOSEAL Matrix has not been established in children under 2 years of age and pregnant women.

Do not use air to remove residual FLOSEAL Matrix from Applicator tip. The Applicator tips should not be cut. Do not use FLOSEAL Matrix on bone surfaces where adhesives, such as methylmethacrylate or other acrylic adhesives, will be required to attach a prosthetic device.

Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.

Site References

1FLOSEAL Hemostatic Matrix Instructions For Use. Hayward, CA: Baxter Healthcare Corporation.
2Oz MC, Cosgrove DM 3rd, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg. 2000;69:1376-1382.
3Oz MC, Rondinone JF, Shargill NS. FloSeal Matrix: new generation topical hemostatic sealant. J Card Surg. 2003;18:486-493.
4Renkens 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.
5Nasso G, Piancone F, Bonifazi R, et al. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg. 2009;88:1520-1526.



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