Prescribing Information Important Risk Information

TISSEEL [Fibrin Sealant] Indications

Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of blunt or penetrating splenic injuries when control of bleeding by conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical. TISSEEL is a hemostatic agent that may be used in fully heparinized patients undergoing cardiopulmonary bypass.

Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

Easyspray System

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EASYSPRAY Pressure Regulator

A control unit that uses pressurized gas for uniform spray delivery. The EASYSPRAY Pressure Regulator enables an aerosolized spray application at the control of the surgeon's fingertip. The EASYSPRAY device is to be used only with spray sets specified for use with this pressure regulator.

For Topical Use Only

EASYSPRAY Set

A disposable set consisting of a dual-lumen connector hose, a sterile filter, 1 spray head, and a clip to be attached to the TISSEEL [Fibrin Sealant] syringe plunger for gas activation. The EASYSPRAY set delivers a thin, uniform film of fibrin sealant over wound surfaces. Surface coverage area is up to 50 cm2 per mL of fibrin sealant versus 4 cm2 per mL with a cannula. The EASYSPRAY Set is designed for use with the EASYSPRAY Pressure Regulator. Available in cases of 10.

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