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Bioseal Fibrin Sealant
Bioseal Fibrin Sealant is a Fibrin sealant / Hemostatic agent Biologic drug developed by Ethicon, Inc.. It is currently FDA-approved for Hemostasis and tissue sealing during general surgery, Hemostasis during cardiovascular surgery, Hemostasis during orthopedic surgery.
Bioseal Fibrin Sealant is a topical hemostatic agent that forms a fibrin clot to seal tissue surfaces and control bleeding during surgery.
Bioseal Fibrin Sealant is a topical hemostatic agent that forms a fibrin clot to seal tissue surfaces and control bleeding during surgery. Used for Hemostasis and tissue sealing during general surgery, Hemostasis during cardiovascular surgery, Hemostasis during orthopedic surgery.
At a glance
| Generic name | Bioseal Fibrin Sealant |
|---|---|
| Sponsor | Ethicon, Inc. |
| Drug class | Fibrin sealant / Hemostatic agent |
| Modality | Biologic |
| Therapeutic area | Surgery / Hemostasis |
| Phase | FDA-approved |
Mechanism of action
The product combines human fibrinogen and human thrombin to create a fibrin clot at the site of application, providing hemostasis and tissue sealing. When the two components mix, thrombin converts fibrinogen to fibrin, which polymerizes to form a stable clot that adheres to tissue surfaces. This mechanical seal helps control bleeding and can be absorbed by the body over time.
Approved indications
- Hemostasis and tissue sealing during general surgery
- Hemostasis during cardiovascular surgery
- Hemostasis during orthopedic surgery
Common side effects
- Infection at surgical site
- Seroma formation
- Allergic reaction
- Thromboembolism (rare)
Key clinical trials
- Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage (PLACE030) (PHASE3)
- Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma. (PHASE2)
- The Bioseal Vascular Study (PHASE4)
- Phase IV Bioseal Study in Brain Tumor Surgery (PHASE4)
- Glue Sealing for Patients With Low-Output ECFs (NA)
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:
- Bioseal Fibrin Sealant CI brief — competitive landscape report
- Bioseal Fibrin Sealant updates RSS · CI watch RSS
- Ethicon, Inc. portfolio CI
Frequently asked questions about Bioseal Fibrin Sealant
What is Bioseal Fibrin Sealant?
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Related
- Drug class: All Fibrin sealant / Hemostatic agent drugs
- Manufacturer: Ethicon, Inc. — full pipeline
- Therapeutic area: All drugs in Surgery / Hemostasis
- Indication: Drugs for Hemostasis and tissue sealing during general surgery
- Indication: Drugs for Hemostasis during cardiovascular surgery
- Indication: Drugs for Hemostasis during orthopedic surgery