FDA clears adjunctive hemostatic agent for cardiac surgery

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The FDA has approved TachoSil (Absorbable Fibrin Sealant Patch) from Baxter International and Nycomed for use as an adjunct to hemostasis in cardiovascular surgery.

TachoSil is an adjunctive hemostatic agent that combines a collagen patch with a coating of human coagulation factors, according to the companies. The patch can be applied directly to the bleeding area either dry or wet. In the presence of saline, blood or other bodily fluids, the coagulation factors dissolve to form a fibrin clot, which adheres the TachoSil patch to the bleeding surface and achieves hemostasis.

TachoSil is a patented product by the Zurich, Switzerland-based Nycomed, and is currently available in approximately 50 markets outside the U.S. The Deerfield, Ill.-based Baxter holds exclusive rights to market and distribute TachoSil in the U.S. Nycomed will manufacture the product and holds the license with the FDA.

Baxter said it plans to launch TachoSil during the second half of 2010.