In April 2015, the US Food and Drug Administration (FDA) approved Raplixa™, the first spray-dried fibrin sealant, to control surgical bleeding. It is approved for use in adults to help control bleeding from small blood vessels when other surgical techniques are not an option.
Raplixa is composed of fibrinogen and thrombin, components in the blood that promote clotting. The two blood components are purified during manufacturing, which includes a viral inactivation step. The product can be applied directly to the site from the vial or sprayed on. It is approved for use in combination with an absorbable gelatin sponge.
In a clinical trial of 719 patients undergoing different types of surgery, Raplixa demonstrated superior clotting capacity compared with an absorbable sponge alone when time to hemostasis was measured.
Raplixa is manufactured by ProFibrix BV, a subsidiary of The Medicine Company, in Parsippany, New Jersey.