FDA approves TachoSil adjunctive hemostatic agent for use in cardiovascular surgery

Baxter International Inc. (NYSE: BAX) and Nycomed today announced the U.S. Food and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil is the first and only adjunctive hemostatic agent available in the U.S. that combines a collagen patch with a coating of human coagulation factors. This ready-to-use 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.

“Controlling bleeding has always been a challenge in cardiovascular surgery, and we are constantly looking for new ways to achieve hemostasis effectively”

"Controlling bleeding has always been a challenge in cardiovascular surgery, and we are constantly looking for new ways to achieve hemostasis effectively," said Dr. Yoshiya Toyoda, M.D., Ph.D., Head of Cardiothoracic Transplantation at the Heart, Lung and Esophageal Surgery Institute at the University of Pittsburgh Medical Center (UPMC). "As a ready-to-use patch, TachoSil represents a new and different option, which I believe will be a welcomed addition to the armamentarium of adjunctive hemostasis products used in cardiovascular surgery today."

TachoSil is a patented Nycomed product that is currently available in more than 50 markets outside of the U.S. 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 plans to launch TachoSil during the second half of 2010.

"TachoSil is the first and only product of its kind approved by the FDA, and an important addition to our BioSurgery line of products," said Ron Lloyd, vice president and general manager of Baxter's Regenerative Medicine business. "The approval of TachoSil and our recently announced acquisition in the orthobiologics space underscore Baxter's commitment to continued growth and leadership across all facets of our BioSurgery business."

SOURCE Baxter International Inc.,