FDA
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T98-22 Print Media: 301-827-6242
May 1, 1998
Consumer Inquiries: 800-532-4440
NEW FIBRIN SEALANT APPROVED
TO HELP CONTROL BLEEDING IN SURGERY
FDA today approved the first of a new class of commercially
available blood-derived products called fibrin sealants that are
applied topically to help control bleeding. Fibrin sealants can
be used to stop oozing from small, sometimes inaccessible, blood
vessels during surgery when conventional surgical techniques are
not feasible. The product is effective for use in
cardiopulmonary bypass and colostomy operations and also in
situations when a traumatic injury to the spleen has occurred.
The main active ingredient of fibrin sealant is fibrinogen,
a protein from human blood that forms a clot when combined with
thrombin -- another blood protein that facilitates blood
clotting. The product works by forming a flexible material over
the oozing blood vessel that can often control bleeding within
five minutes.
Although many surgeons have legally prepared their own
fibrin sealants, these locally prepared products are not
standardized or consistent, and the available sources of
fibrinogen are not virally inactivated.
This product is manufactured by Oesterreichisches Institut
Fuer Haemoderivate G.M.B.H. in Vienna, Austria and distributed by
Baxter Healthcare Corporation, Glendale, Calif. under the brand
name TISSEEL.
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