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Baxter announces FDA approval of hemostatic device

Baxter Healthcare has reported that the FDA has approved Gelfoam plus hemostasis kit, a hemostatic device for surgical procedures when control of capillary, venous and arteriolar bleeding by pressure, ligature and conventional procedures is either ineffective or impractical.

Baxter and Pfizer signed marketing, supply and manufacturing agreement for Gelfoam plus hemostasis kit. Under the terms of the agreement, Baxter is the exclusive distributor of Gelfoam plus hemostasis Kit. Pfizer will provide the sterile Gelfoam gelatin absorbable sponge and Baxter will assemble, distribute and promote the Gelfoam plus hemostasis Kit.

David Engels, senior director, US diversified products at Pfizer, said: “Gelfoam plus will be well received in the surgical field as it provides a practical solution using the existing Gelfoam product with Baxter’s human thrombin and has also been shown to be more effective for achieving hemostasis than the use of Gelfoam wetted with saline.”