StatSeal products are based on Biolife’s revolutionary technology. The product ingredients are a mixture of a hydrophilic polymer and potassium ferrate. The mechanism of action is a simultaneous two-step action whereby the hydrophilic polymer rapidly dehydrates the blood and absorbs exudate while the potassium ferrate agglomerates the blood proteins to create a seal or physical barrier over a wound or procedural site.
StatSeal products do not depend on the body’s natural clotting mechanism to form a seal, so it can be used for patients prone to bleeding. The initial seal forms immediately upon contact with blood or exudate. The seal strengthens when manual pressure is applied over the powder and clotting occurs naturally below the seal.
In-vitro testing has shown that the pH of the proximal side of the seal is neutral, while on the distal side it is quite low (~2).
This technology has been cleared by the FDA 510k process #K080210