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Fibrin Sealant (Human News
Posted 30 Apr 2015 by Drugs.com
April 30, 2015 – The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery. Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. Raplixa contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the ... Read more
Baxter Announces FDA Approval of Artiss Fibrin Sealant for Use in Face-Lift (Facial Rhytidectomy) Procedures
Posted 31 Aug 2011 by Drugs.com
DEERFIELD, Ill.--(BUSINESS WIRE)--Aug 31, 2011 - Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has expanded the indication of Artiss [Fibrin Sealant (Human)] to include adhering tissue flaps during facial rhytidectomy surgery (face-lift). Artiss is the only premixed, ready-to-use fibrin sealant specifically indicated for tissue adherence in facial rhytidectomy (face-lift) and burn surgeries. It was first approved by the FDA in 2008 to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations one year of age or older. “The use of Artiss in this indication gives surgeons a useful tool to enable full-surface adherence of tissue flaps during surgery, minimizing areas of dead space, and significantly reducing drainage volumes when compared to standard of care,” said Dr. Thomas Mustoe, Pr ... Read more