Surgical Hemostat Assists Clotting

A surgical hemostat assists clotting when conventional means fail or are impractical, and is then absorbed by the body.

This new hemostat is intended for use during surgical procedures (except neurosurgery and eye surgery) and includes the biologic component thrombin, an enzyme that assists in the clotting of blood. It is intended to assist clotting when control of bleeding using suture or other conventional procedures is not effective or seems impractical.

The hemostat uses autologous blood as opposed to products from pooled donor blood, thus reducing the risk of transmission of diseases associated with donor blood. The primary mode of clotting is the formation of a protein (collagen/fibrin) clot that serves as a physical barrier to blood flow. The thrombin component helps form a clot by converting the protein fibrinogen to fibrin during clotting. After performing its function, the device is absorbed by the body.
Called Vitagel, the device has been shown to be effective in controlling bleeding in hepatic, general, cardiac, and orthopedic surgical procedures. The most common adverse events observed in the treated patients were fever, pain, nausea, and collapse of a lung (atelectasis). Vitagel should not be injected into blood vessels or be used in surgical situations where it may enter a blood vessel, as it could cause a clot to form in a blood vessel causing serious damage and death. Also, it should not be used in patients who are allergic to materials of bovine origin.

Vitagel was developed by Orthovita (Malvern, PA, USA) and has been cleared by the U.S. Food and Drug Administration (FDA).


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