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Omrix gets US OK for second-generation fibrin sealant, looks to new markets:

This article was originally published in Clinica

Executive Summary

Omrix Biopharmaceuticals has gained US clearance to sell its second-generation fibrin sealant to control bleeding during liver surgery, and has also announced plans to broaden its target market. The new sealant, Evicel, differs from its previous fibrin sealant, Crosseal, in that it does not contain a stabiliser, and will, therefore, not have the neurosurgical contraindication presented by the earlier product. As for new applications, the New York company has submitted an application to the FDA to expand Evicel's indication to include vascular surgery. It is also conducting a clinical study of the sealant in kidney surgery. An indication for general haemostasis requires the completion of at least three pivotal clinical studies, of which the firm has now completed two - liver and peripheral vascular surgery. Omrix' haemostasis products are distributed by Johnson & Johnson firm Ethicon.

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