First Spray-Dried Sealant OK’d for Bleeding During Surgery

The Food and Drug Administration (FDA) has approved Raplixa (fibrin sealant [human]; ProFibrix) to help control bleeding during surgery when other surgical techniques (eg, suture, ligature, cautery) are ineffective or impractical. Raplixa is the first spray-dried fibrin sealant to be approved.

Raplixa, a biological agent, is dissolved in the blood and triggers a reaction between fibrinogen and thrombin proteins. This reaction leads to blood clot formations to help stop the bleeding. Raplixa contains fibrinogen and thrombin, which are two proteins found in human plasma. They are individually purified through a process that involves virus inactivation and removal to reduce the risk of blood-borne viral transmission. Then the fibrin sealant components are spray-dried, blended, and packed in a via. Raplixa is approved for use in conjunction with an absorbable gelatin sponge.

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The FDA reviewed data from a study (n=719) over 11 months in patients undergoing various surgeries. The study demonstrated the efficacy of Raplixa by comparing the reduction in time needed for bleeding to stop when using the fibrin sealant an vs. using an absorbable sponge alone.

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