Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FS VH S/D 500 s-apr · 1 trial · 1 indication
Participants who have no intra-operative CSF leak from dural repair after up to two applications during Valsalva maneuver (25 cm H2O for up to 5 - 10 seconds), or post-operative CSF leak within 30 (+3) days post-operatively. The Valsalva maneuver was performed by the anaesthesiologist to increase the intra-thoracic pressure (e.g., by increasing the positive end-expiratory pressure or by giving a large tidal volume and holding the inflating pressure) to approximately 25 cm H2O, constantly for up to 5 - 10 seconds to transiently elevate the intracranial pressure and test for any CSF leaks. The suture line was to be watertight after up to two product/control applications and Valsalva maneuvers.
| Arm | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | EXPERIMENTAL | FS VH S/D 500 s-apr (Tisseel), single use treatment, intraoperative |
| DuraSeal Dural Sealant | ACTIVE_COMPARATOR | DuraSeal Dural Sealant, single use treatment, intraoperative |
| Name | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | DRUG | - |
| DuraSeal Dural Sealant | DEVICE | - |
Inclusion Criteria: 1. Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST region 2. Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed 3. Patients must be willing to receive per...
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.