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FS VH S/D 4 s-apr
FS VH S/D 4 s-apr is a solvent/detergent-treated fresh frozen plasma product designed to provide clotting factors and other plasma proteins while reducing the risk of viral transmission.
FS VH S/D 4 s-apr is a solvent/detergent-treated fresh frozen plasma product designed to provide clotting factors and other plasma proteins while reducing the risk of viral transmission. Used for Coagulation factor deficiency requiring plasma transfusion, Reversal of warfarin or other vitamin K antagonists, Massive transfusion protocols.
At a glance
| Generic name | FS VH S/D 4 s-apr |
|---|---|
| Also known as | ARTISS |
| Sponsor | Baxter Healthcare Corporation |
| Drug class | Fresh frozen plasma (pathogen-reduced) |
| Modality | Biologic |
| Therapeutic area | Hematology / Transfusion Medicine |
| Phase | Phase 3 |
Mechanism of action
This is a pathogen-reduced fresh frozen plasma (FFP) product manufactured by Baxter using solvent/detergent (S/D) treatment technology. The S/D process inactivates enveloped viruses (such as HIV, hepatitis C, and hepatitis B) by disrupting their lipid membranes, while preserving the coagulation factors and other plasma proteins needed for hemostasis. It is intended for transfusion in patients with coagulation factor deficiencies.
Approved indications
- Coagulation factor deficiency requiring plasma transfusion
- Reversal of warfarin or other vitamin K antagonists
- Massive transfusion protocols
Common side effects
- Transfusion-related acute lung injury (TRALI)
- Allergic reaction
- Circulatory overload
- Febrile non-hemolytic transfusion reaction
Key clinical trials
- Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty (PHASE2)
- Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection (PHASE2)
- FS VH S/D 500 S-apr in Vascular Surgery (PHASE3)
- Fibrin Sealant Vascular Surgery Study (PHASE2)
- Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy (PHASE3)
- Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FS VH S/D 4 s-apr CI brief — competitive landscape report
- FS VH S/D 4 s-apr updates RSS · CI watch RSS
- Baxter Healthcare Corporation portfolio CI