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TISSEEL VH fibrin sealant · 1 trial · 3 indications
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) | DRUG | - |
| TISSEEL VH fibrin sealant | DRUG | - |
Inclusion Criteria: All subjects accepted for this study must be: * Informed of the nature of the study and have provided written informed consent * \>= 18 years of age * Scheduled to undergo cardiac surgery requiring CPB and median sternotomy * Able and willing to comply with the procedures requi...
TISSEEL VH fibrin sealant is used in cardiac surgery requiring cardiopulmonary bypass and median sternotomy. It is a fibrin sealant designed to provide hemostatic efficacy during these procedures. The product is developed by Baxter International Inc. and has been studied in a Phase 3 clinical trial.
TISSEEL VH fibrin sealant is made by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX. Baxter develops and markets this fibrin sealant for use in cardiac surgery procedures.
TISSEEL VH fibrin sealant is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind study. The product is investigational and has not been reported as FDA approved.
TISSEEL VH fibrin sealant has been studied in one completed Phase 3 trial, identified as NCT00161733. This trial evaluated the safety and hemostatic efficacy of the fibrin sealant compared with a currently licensed version in subjects undergoing cardiac surgery in the United States.
TISSEEL VH fibrin sealant is related to FS VH S/D, which stands for Fibrin Sealant Vapor Heated, Solvent/Detergent Treated. The Phase 3 trial NCT00161733 compared FS VH S/D with the currently licensed TISSEEL VH fibrin sealant, indicating they are distinct formulations.