Firm gains expanded FDA approval via biologic license application supplement to market its Tisseel fibrin sealant for general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical, Baxter International Inc. announced Jan. 30. Previously, the human plasma-based fibrinogen/thrombin sealant was approved as an adjunct to hemostasis in cardiopulmonary bypass and spleen repair, as well as a sealant for colostomy (colon rupture) closure. (See [A#01240180003].) “The new indication allows Tisseel to be used for hemostasis in a variety of surgical situations rather than just in surgeries involving cardiopulmonary bypass and treatment of blunt or penetrating splenic injuries,” a Baxter spokesperson told “The Gray Sheet,” such as open and laparoscopic procedures. It is designed to mimic the body’s own blood clotting cascade to create a clot that adheres to the wound surface and helps achieve hemostasis, Baxter says.
St. Jude Medical Inc. subsidiary Irvine Biomedical Inc. gains PMA approval for its Therapy Cool Path Duo/Safire BLU...