Evithrom (human thrombin) FDA-approved for Topical Use in Surgery

Filed in archive FDA Approvals , Treatment on August 29, 2007

Evithrom (human thrombin) - manufactured by Omrix Biopharmaceuticals, Ltd. and will be distributed by Johnson & Johnson Wound Management (a division of Ethicon, Inc.) - is the first human thrombin approved since 1954 and the only product currently licensed.




Evithrom was derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.

Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical.

The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable Gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.

With this approval, surgeons will now have to choose between human thrombin and thrombin derived from cattle plasma.

Now I wonder which one is more effective and not to mention cost-efficient.

Source: FDA News