VISTASEAL
The FDA provided updated information regarding the indication for VISTASEAL [Fibrin Sealant (Human)], which is used as an adjunct to hemostasis for mild to moderate bleeding in adults during surgery.
Manufacturers of human fibrin sealants, surgical teams, and regulatory professionals managing biologics for perioperative use.
The limitation of the indication to 'mild to moderate bleeding' and its status as an 'adjunct' when standard techniques (suture, ligature, cautery) are impractical suggests a narrow clinical window. Regulatory teams must ensure that promotional and clinical materials do not imply the product is a primary hemostatic agent or suitable for severe hemorrhaging based on this source text.
Regulatory and clinical teams should ensure surgical protocols and labeling reflect the product's role as an adjunct only when standard techniques are ineffective. Documentation should support use specifically for mild to moderate bleeding in adult populations.
Fibrin Sealant lead page - FIBRIN SEALANT (Human) is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. FIBRIN SEALANT (Human)
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