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Baxter Announces FDA Approval of GELFOAM(R) Plus Hemostasis Kit
Date:12/17/2007

. Baxter's human thrombin is derived from human plasma and is used as a component in hemostatic agents and sealants for adjunctive therapy during surgical procedures.

About GELFOAM Plus Hemostasis Kit

GELFOAM Plus Hemostasis Kit is indicated as a hemostatic device for surgical procedures when control of capillary, venous, and arteriolar bleeding by pressure, ligature and conventional procedures is ineffective or impractical. Human thrombin used without the GELFOAM Sterile Sponge is not indicated for hemostasis.

Important Safety Information

GELFOAM Plus should not be used in closure of skin incisions, because it may interfere with the healing of the skin edges. GELFOAM Plus should not be placed intravascularly, because of the risk of embolization.

GELFOAM Plus is not recommended for use other than an adjunct for hemostasis.

GELFOAM Plus contains thrombin, which is made from human plasma. It may carry the risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent.

While packing a cavity for hemostasis is sometimes surgically indicated, GELFOAM Plus should not be used in this manner unless excess product not needed to maintain hemostasis is removed. Whenever possible, GELFOAM Plus should be removed after use in laminectomy procedures and from foramina in bone, once hemostasis is achieved. This is because GELFOAM Plus may swell to its original size on absorbing fluids and produce nerve damage by pressure within confined bony spaces.

GELFOAM Plus is not recommended in the presence of infection. There have been reports of fever associated with the use of GELFOAM Sterile Sponge, without demonstrable infection.

RX Only: For safe and proper use of GELFOAM Plus, please refer to full Instructions For Use. http://www.pfizer.com/files/products/uspi_gelfoam_plus.pdf

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SOURCE Baxter Healthcare Corporation
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