Baxter announced that the FDA has expanded the indication for Tisseel (fibrin sealant) to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical. It is effective in heparinized patients. This approval was based on data from a Phase 3 study of Tisseel in peripheral vascular surgery compared with manual compression, a standard of care, in 140 evaluable patients. In the study, Tisseel was shown to be statistically significantly better than manual compression in achieving hemostasis.
Tisseel is already indicated as an adjunct to standard surgical techniques to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.
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