FDA Approves Fibrin Sealant to Control Bleeding During Surgery
The FDA today approved the first spray-dried fibrin sealant to be used to control bleeding during surgery.
The FDA today approved the first spray-dried fibrin sealant (Raplixa) to be used to control bleeding during surgery.
The product, which comes in the form of a vial, can be used to help manage bleeding when surgical techniques, such as suture, ligature, or cautery, are not effective.
Raplixa can be used to start a reaction between fibrinogen and thrombin proteins, which can help form blood clots to stop bleeding, according to a FDA press release.
Raplixa’s approval was based on a trial of 719 patients undergoing several surgical procedures. Raplixa was shown to reduce the time needed to stop bleeding during surgery when compared with an absorbable sponge.
Potential adverse side effects may include surgical pain, nausea, constipation, fever, and decreased blood pressure.
“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.”