Spray-Dried Sealant Helps Control Surgical Bleeding

A novel spray-dried human fibrin sealant helps control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature, or cautery are ineffective or impractical.

Raplixa contains powdered fibrinogen and thrombin that are purified, spray-dried, blended, and packaged in a vial, using a manufacturing process that includes virus inactivation and other steps that help reduce the risk of transmission of blood-borne viruses. Each gram of Raplixa contains 79 mg human fibrinogen and 726 IU human thrombin, and the powder is available in three different presentations: 0.5, 1.0, and 2.0 grams.

Raplixa requires no thawing, reconstitution, or mixing, and can be applied either directly from the vial or with the RaplixaSpray device, a low-pressure spray applicator designed to reach larger bleeding surfaces and difficult to reach areas by using medical CO2 gas or medical grade air as the propellant. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.

The fibrin monomers then aggregate and form a fibrin clot. Factor XIIIa, which is activated from factor XIII by thrombin, then cross-links the fibrin. As wound healing progresses, increased fibrinolytic activity is induced by plasmin, causing the fibrin to degrade. Raplixa is a product of The Medicines Company (Parsippany, NJ, USA), and has been approved for use by the US Food and Drug Administration (FDA) for use in conjunction with an absorbable gelatin sponge.

“Controlling mild to moderate bleeding during surgery requires a hemostatic agent that is easy-to-use and works well across a range of bleeding settings,” said Grant Bochicchio, MD, MPH, of Washington University School of Medicine (St. Louis, MO, USA). “RAPLIXA and the RaplixaSpray device provide surgeons with a potential off-the-shelf solution ready to address the challenging bleeding situations we encounter every day.”

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The Medicines Company