Hemostatic gel Floseal

neurosurgerycardiovascular surgery

Overview
Floseal Hemostatic Matrix is a flowable, active hemostat composed of an absorbable gelatin matrix combined with recombinant thrombin (Recothrom® Thrombin Topical, Recombinant). It is indicated as an adjunct to hemostasis in surgical procedures (excluding ophthalmic surgery) when conventional methods such as ligature or cautery are ineffective or impractical.

Key benefits

• Rapid preparation and hemostasis: prepares in approximately one minute with potential to achieve hemostasis in as little as 60 seconds in some clinical reports (median time to hemostasis 1.5 minutes in a referenced RCT).
• Recombinant thrombin (Recothrom®) contains no human blood components and is structurally similar to human thrombin, eliminating reliance on human blood donations.
• Clinically effective across multiple surgical specialties with high reported hemostasis rates and demonstrated reductions in blood product transfusion in cardiac surgery studies.

Unique mechanism of action
Floseal Matrix acts at multiple points in the coagulation process: gelatin granules promote contact activation and platelet aggregation while thrombin converts fibrinogen to fibrin to accelerate clot formation. Gelatin granules swell approximately 10–20% within about ten minutes upon contact with blood or fluids, contributing a tamponade effect.

Clinical performance & evidence

• Fast preparation and documented rapid hemostasis in randomized and real-world studies.
• Clinical data in cardiac surgery showing reductions in transfusion requirements (example comparative data reported in referenced studies).
• Supported by published randomized controlled trials and observational literature across surgical settings.

Indications
Indicated as an adjunct to hemostasis in surgical procedures (other than ophthalmic) when bleeding cannot be controlled by ligature or conventional procedures or when such methods are impractical.

Important risk information and contraindications

• Do not inject intravascularly or compress into blood vessels.
• Do not apply in the absence of active blood flow (for example while a vessel is clamped or bypassed) — extensive intravascular clotting and death may result.
• Do not administer to patients with known hypersensitivity to Recothrom®, any component of Recothrom®, or hamster proteins; hypersensitivity reactions including anaphylaxis may occur.
• Do not use in patients with known allergies to bovine-derived materials.
• Not intended for closure of skin incisions; may interfere with skin-edge healing due to mechanical interposition of gelatin.
• Not a substitute for meticulous surgical technique or for prophylactic hemostasis.
• Avoid use where negative peripheral venous pressure may draw material into the vascular system; remove excess non-incorporated material by gentle irrigation and suction.
• Not intended for use in infected sites; use with caution in contaminated areas.
• Safety and effectiveness not established for ophthalmic procedures, postpartum hemorrhage, menorrhagia, children under 2 years of age for Floseal Matrix (Recothrom labeling includes pediatric details for topical thrombin products), or in pregnant women where safety is not established.
• Do not use air to expel residual material from the applicator tip; do not cut applicator tips.
• Antibody formation to Recothrom® occurred in <1% of patients; no neutralization of native human thrombin reported.
• Single use only; do not resterilize. Thrombin must be added to the gelatin matrix prior to use.

Preparation and use
Prepare Floseal Matrix by combining the gelatin matrix with the thrombin component (Recothrom®) immediately before application. Preparation is rapid (approximately one minute in referenced time‑and‑motion studies). Apply to the bleeding site without compressing the material; remove excess material not incorporated in the clot by gentle irrigation and suction. When placed into cavities or closed tissue spaces, gentle tissue approximation is recommended.

Clinical & historical context
Floseal Matrix utilizes recombinant DNA technology for its thrombin component and has been used in clinical practice for over 25 years with published evidence supporting favorable hemostatic outcomes and hospital resource utilization metrics.

Specifications / technical characteristics

• Product: Floseal Hemostatic Matrix (flowable gelatin matrix with thrombin).
• Thrombin component: Recothrom® Thrombin Topical (Recombinant).
• Gelatin granule swelling: approximately 10–20% within ~10 minutes upon contact with blood/fluids (tamponade effect).
• Typical preparation time: ~1 minute.
• Potential time to hemostasis: as little as 60 seconds in some studies; median 1.5 minutes reported in an RCT for spinal surgery.
• Clinical effectiveness: high reported hemostasis rates across specialties and demonstrated transfusion reductions in cardiac surgery studies.
• Not for ophthalmic use; not for intravascular injection; single‑use device; thrombin must be added prior to application.