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FS VH S/D 4 s-apr · 1 trial · 2 indications
Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).
| Arm | Type | Description |
|---|---|---|
| FS VH S/D 4 s-apr | EXPERIMENTAL | One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
| Standard of Care (SoC) | NO_INTERVENTION | Other side of face will receive standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
| Name | Type | Description |
|---|---|---|
| FS VH S/D 4 s-apr | BIOLOGICAL | FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area. |
Inclusion Criteria: * Male or female subject is 18 to 75 years of age at the time of screening * Subject is planned for facial rhytidectomy * Subject has read, understood and signed the written informed consent * Subject is healthy, as determined by the investigator using standard pre-operative ass...
FS VH S/D 4 s-apr is a fibrin sealant used as an adjunct to sutured dural repair in cranial surgery to prevent cerebrospinal fluid leak, and for flap adherence in rhytidectomy, commonly known as a face-lift. It is a monoclonal antibody modality developed by Baxter International Inc.
FS VH S/D 4 s-apr is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX. The product is being studied for use in face-lift procedures and as an adjunct to sutured dural repair in cranial surgery.
FS VH S/D 4 s-apr is in Phase 3 clinical development. It has completed two Phase 3 trials, one for flap adherence in rhytidectomy and one for cerebrospinal fluid leak prevention in cranial surgery. The product remains investigational and is not approved for commercial use.
FS VH S/D 4 s-apr has completed two Phase 3 trials. NCT00999141 evaluated its efficacy and safety for flap adherence in rhytidectomy with 75 participants in the United States. NCT02891070 assessed it as an adjunct to sutured dural repair in cranial surgery with 224 participants across the United States, Czechia, Germany, and Spain.
FS VH S/D 4 s-apr is related to Tisseel, as the trial NCT02891070 refers to the product as FS VH S/D 500 S-apr (Tisseel). This indicates that FS VH S/D 4 s-apr and Tisseel are formulations of the same fibrin sealant product family developed by Baxter.