FDA approves new thrombin clotting solution for surgery

March 19, 2008

The Food and Drug Administration recently announced that it has approved a clotting solution made using recombinant DNA techniques, called Recothrom, to help stop bleeding of small blood vessels during surgery. In addition, the FDA has expanded the indication of Evicel-a liquid fibrin sealant previously approved for liver and vascular surgeries-to include its use during general surgery.

The Food and Drug Administration recently announced that it has approved a clotting solution made using recombinant DNA techniques, called Recothrom, to help stop bleeding of small blood vessels during surgery. In addition, the FDA has expanded the indication of Evicel-a liquid fibrin sealant previously approved for liver and vascular surgeries-to include its use during general surgery.

Recothrom is a topical thrombin solution that surgeons can apply to reduce bleeding from capillaries and other small blood vessels during surgery when other techniques to stop blood loss fail. The recombinant thrombin in the solution is produced from Chinese hamster ovary cells that have been genetically modified to produce human thrombin. Recothrom is manufactured by ZymoGenetics, Inc., of Seattle.

Evicel, a liquid fibrin sealant, is applied during surgery to small oozing blood vessels, and helps to form a covering to stop bleeding. The sealant contains fibrinogen and thrombin, two proteins that promote the formation of fibrin. Evicel is produced by OMRIX biopharmaceuticals LTD, Kiryat Ono, Israel.

News Release, January 27, 2008: FDA Approves First Clotting Solution Made Using Recombinant DNA Technology. Available at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01779.html.