SURGIFLO™ Hemostatic Matrix Kit
SURGIFLO™, the market leader in flowable gelatin hemostasis category, is backed by robust clinical data demonstrating efficacy, safety, and efficiency.1-3A In a double-blind study, 95% of surgeons preferred SURGIFLO™ over FLOSEAL + RECOTHROM for its ability to stay in place, reach difficult-to-access anatomy, flow predictability, maintain paste consistency, not break apart and be expressed easily.4B With the same trusted efficacy, SURGIFLO™ Hemostatic Matrix Kit with Thrombin is now faster, simplier, and more consistent to prepare.5C
About this device
SURGIFLO™ Hemostatic Matrix Kit, mixed with sterile saline or thrombin solution, is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. This flowable gelatin matrix can be prepared inside or outside the sterile field and can be used in laparoscopic surgery to control bleeding. With simplified preparation, SURGIFLO™ (SF2995) requires minimal training and offers a short learning curve for nurses of all experience levels.5
Clinical outcomes
SURGIFLO™ is backed by robust clinical data demonstrating efficacy, safety, and efficiency—including a meta-analysis of 6 clinical studies across 39,660 patients.6 The following endpoints were assessed:
In a double-blind study, 95% of surgeons preferred SURGIFLO™ to FLOSEAL + RECOTHROM for its ability to stay in place, flow predictably, not break apart, reach difficult-to-access anatomy, maintain paste consistency , and express easily.4D
- Blood transfusions
- Surgical / Operating time
- Length of stay
- Minor & major complications
- Hemostasis in <7 minutes
In a double-blind study, 95% of surgeons preferred SURGIFLO™ to FLOSEAL + RECOTHROM for its ability to stay in place, flow predictably, not break apart, reach difficult-to-access anatomy, maintain paste consistency , and express easily.4D
Economic benefits
In a large retrospective spine surgery study comparing FLOSEAL™ Matrix vs. SURGIFLO™, SURGIFLO™ was associated with:
- Shorter mean length of stay (LOS)7E
- Significantly lower risk for ICU admission7F (6.6% vs 11.7%, respectively, P<.0001)
- Significantly shorter operating room time8GH
Features & benefits
Stops bleeding rapidly
SURGIFLO™ stays in place even during active bleeding.9,10I The applicator allows for precise placement to address bleeding in tight and difficult-to-access sites.11,12
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Uniform viscosity
SURGIFLO™ Hemostatic Matrix maintains uniform consistency and viscosity from beginning to end.13J
Unbeatable preparation time5,14C
SURGIFLO™ Hemostatic Matrix Kit (SF2995) with Thrombin has more than 2.5 x faster preparation time than FLOSEAL + RECOTHROM.5K The vial adapter for SF2995 is designed for smooth and easy stopper penetration and the enhanced luer lock provides a secure connection for fast preparation.5C
Optimized adherence
Optimized for consistency and tissue adherence,15-17L filling bleeding sites to stop bleeding fast.11,12,18,19
Learn how to use this device
Supporting documentation
Product resources
Evidence resources
SURGIFLO™ Hemostatic Matrix Kit Brochure
SURGIFLO™ Hemostatic Matrix Kit Vac Pack
SURGIFLO™ Hemostatic Matrix Kit Value Story
SURGIFLO™ Hemostatic Matrix Kit Versus FLOSEAL Updated Competitive Grid
SURGIFLO™ Hemostatic Matrix Kit Versus Floseal With Recothrom Competitive Grid
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VISTASEAL™ Fibrin Sealant (Human)
Mimicking the body's clotting process, VISTASEAL™ Fibrin Sealant (Human) forms a rapid, adherent, and durable clot, even in patients with challenging coagulation profiles.1-4 A simplified preparation process offers flexible application—you can easily drip or spray it, adjusting seamlessly to your surgical approach.
VISTASEAL™ can be thawed in the refrigerator (2-8°C, 36-48°F) and stored in the refrigerator for 7 days after thawing if it remains sealed in the original packaging.1
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EVARREST™ Fibrin Sealant Patch
EVARREST™ Fibrin Sealant Patch innovation offers superior hemostatic efficacy on the first attempt.*1-4 Hemostasis is achieved with EVARREST™ Fibrin Sealant Patch when the formed fibrin clot integrates with the patch component and adheres to the wound surface, thus also providing a physical barrier to bleeding.5
*EVARREST™ demonstrated hemostatic superiority across 4 clinical trials. Trial 1: Soft Tissue hemorrhage: Per protocol efficacy measured at n=87, 100% vs 53.3% for Surgicel Δ 46.7% P<0.0001; (ITT population=90). Trial 2: Normal and Abnormal liver resection hemorrhage: Per protocol efficacy measured at n=77, 94.3% vs 28.6% for conventional adjunctive methods Δ 65.7% P<0.001; (ITT population=84). Trial 3: Anatomic and nonanatomic liver resection hemorrhage: Per protocol efficacy measured at n=93, 97.9% vs 44.4% for conventional adjunctive methods Δ 53.5% P<.0001; (ITT population=102). Trial 4: Aortic reconstruction: Per protocol efficacy measured at n=141, 78.8% vs 46.7% for Tachosil Δ 32.1% P<0.0001; (ITT population=156).
SURGICEL™ Powder Absorbable Hemostat
Penetration that gets to the source - for efficient hemostasis in broad-surface bleeds.1,2A SURGICEL™ Powder, the latest in SURGICEL™ innovation, provides a unique, powdered structure that penetrates beyond the surface of a bleed3 - with no prep needed and a ready-to-use application.2 It is proven bactericidal in vitro against a broad range of gram-positive and gram-negative organisms, including various antibiotic-resistant bacteria (MRSA, VRE, PRSP and MRSE).2B
References
SURGIFLO™ Hemostatic Matrix Kit Essential Product Information (Made from Absorbable Gelatin Sponge, USP) with Thrombin
DESCRIPTION SURGIFLO™ with Thrombin (SURGIFLO™ Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.
ACTIONS When used in appropriate amounts SURGIFLO™ is absorbed completely within 4 to 6 weeks.
INTENDED USE/INDICATIONS SURGIFLO™, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
CONTRAINDICATIONS
ADVERSE EVENTS
A total of 142 patients received SURGIFOAM™ Sponge during a clinical trial comparing SURGIFOAM™ Sponge to another absorbable gelatin sponge. In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:
Adverse Reactions to Gelatin-Based Hemostatic Agents with Thrombin
Adhesion formation and small bowel obstruction are well-known and common complications following abdominal and gynecological surgeries. Adverse events such as these, as well as inflammation and foreign body reaction including giant cell granulomas, have been reported within abdominal and gynecological surgeries in which gelatin-based and collagen-based hemostatic agents with thrombin have been used in excessive amount. Inflammation and foreign body reaction such as encapsulation of the product may mimic artifacts on radiographic images, resulting in diagnostic errors and possible reoperation. Therefore, as with other gelatin hemostatic agents, only the minimum amount of SURGIFLO™ Hemostatic Matrix needed to achieve hemostasis should be used. Once hemostasis is achieved, any excess SURGIFLO™ Hemostatic Matrix should be carefully removed.
EVITHROM™ Thrombin, Topical (Human) for Topical Use Only Lyophilized Powder for Solution EVITHROM™ is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM™ may be used in conjunction with an Absorbable Gelatin Sponge, USP.
Important Safety Information
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
US_ETH_BIOS_111036.1
EVARREST™ Fibrin Sealant Patch Important Safety Information
Indications and Usage
EVARREST™ is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
Limitations for Use
• Cannot be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding.• Not for use in children under one month of age
• Laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve.
Dosage and Administration
For topical use only
• Determine the number of patches to be applied based upon the surface area and anatomic location of the bleeding tissue to be treated.
• Keep the patch dry until use.
• Place the powdery (active) side of the patch on the surface of tissue.
• Apply immediate manual compression over the entire surface of the patch and maintain contact pressure for 3 minutes to control the bleeding.
Dosage Forms and Strengths
EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component. The active side is powdery, and the non-active side has an embossed wave pattern.
Each 2 x 4 inch (5.1 x 10.2 cm) absorbable patch contains:
• 55.5 mg per square inch (8.6 mg per square cm) human fibrinogen
• 241.9 Units per square inch (37.5 Units per square cm) human thrombin
Contraindications
• Do not use to treat bleeding from large defects in arteries or veins.
• Do not apply intravascularly.
• Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
Warnings and Precautions
• Thrombosis can occur if absorbed systemically. Apply topically to the bleeding site only.
• Can cause hypersensitivity reactions including anaphylaxis.
• Avoid application to contaminated areas of the body or in the presence of active infection. Infection can occur.
• EVARREST™ contains oxidized regenerated cellulose which adheres to bleeding surfaces. Inadvertent adhesions can occur.
• Avoid use in, around, or in proximity to, foramina in bone or areas of bony confine where swelling may cause compression.
• Use the least number of patches required to cover the entire bleeding area.
• May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse Reactions
The adverse reactions reported during clinical trials occurred in less than 1% of all cases and included deep venous thrombosis, pulmonary embolism, blood fibrinogen increase, anastomotic hemorrhage, post procedural and intra-abdominal hemorrhage, abdominal distension, anemia, gastrointestinal hemorrhage, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, localized intra-abdominal fluid collection, cardiac failure, operative hemorrhage, and ischemic bowel.
To report SUSPECTED ADVERSE REACTIONS, contact ETHICON Customer Support Center at 1-877-384-4266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pediatric: Use in children under the age of one month may be unsafe or ineffective due to small size and limited ability to apply the patch as recommended.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
US_SRG_BIOS_125120.1
VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
INDICATION
VISTASEAL™, a fibrin sealant, is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL™ is effective in heparinized patients.
CONTRAINDICATIONS
Do not inject directly into the circulatory system.
Do not use for the treatment of severe or brisk arterial bleeding.
Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.
Do not use VISTASEAL™ for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.
WARNINGS AND PRECAUTIONS
Thromboembolic events may occur if VISTASEAL™ is administered intravascularly.
Hypersensitivity reactions can occur.
May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
ADVERSE REACTIONS
The most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
US_ETH_BIOS_110059.2
A. US market leadership measured in unit volume.
B. SURGIFLO™ Hemostatic Matrix Kit with Thrombin was evaluated in a double-blind qualitative market research study of 40 surgeons from a variety of specialties.
C. Compared to SURGIFLO™ 2994 Hemostatic Matrix Kit with Thrombin and Floseal with Recothrom
D. SURGIFLO™ Hemostatic Matrix Kit with Thrombin was evaluated in a double-blind qualitative market research study of 40 surgeons from a variety of specialties.
E. P=0.0016
F. In a large retrospective nationwide hospital database assessing SURGIFLO™ and Floseal in a spine surgery population.
G. In a retrospective study of 28,910 spinal surgery patients from the Premier Healthcare Database.
H.P=0.0001.
I. In animal models.
J. Based on in vitro viscosity testing of SURGIFLO™ 8 mL and FLOSEAL Hemostatic Matrix 5 mL; each product was prepared following Instructions for Use.
K. Compared to Floseal with Recothrom
L. Compared to previous SURGIFLO™ version
The third-party trademarks used herein are trademarks of their respective owners.
© Johnson & Johnson and its affiliates 2026. US_SRG_BIOS_131297.2
DESCRIPTION SURGIFLO™ with Thrombin (SURGIFLO™ Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.
ACTIONS When used in appropriate amounts SURGIFLO™ is absorbed completely within 4 to 6 weeks.
INTENDED USE/INDICATIONS SURGIFLO™, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
CONTRAINDICATIONS
- Do not use SURGIFLO™ in intravascular compartments because of the risk of embolization.
- Do not use SURGIFLO™ in patients with known allergies to porcine gelatin.
- Do not use SURGIFLO™ in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
- SURGIFLO™ Hemostatic Matrix is not intended for prevention of bleeding. The use of SURGIFLO™ Hemostatic Matrix for mechanical support has not been studied.
- SURGIFLO™ should not be used in the presence of infection and should be used with caution in contaminated areas of the body.
- SURGIFLO™ should not be used in instances of pumping arterial hemorrhage. SURGIFLO™ will not act as a tampon or plug in a bleeding site.
- SURGIFLO™ should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm because it may swell resulting in nerve damage.
- Excess SURGIFLO™ should be removed once hemostasis has been achieved.
- The safety and effectiveness of SURGIFLO™ for use in ophthalmic procedures has not been established.
- SURGIFLO™ should not be used for controlling post-partum intrauterine bleeding or menorrhagia.
- The safety and effectiveness of SURGIFLO™ has not been established in children and pregnant women.
- The blue flexible applicator tip should not be trimmed to avoid exposing internal guidewire.
- The white straight applicator tip should be trimmed away from the surgical area. Cut a square angle to avoid creating a sharp tip.
- Safe and effective use of SURGIFOAM™ Sponge has been reported in a published neurologic retrospective study involving 1700 cases in Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.
- SURGIFLO™ Hemostatic Matrix is for single use only. Do not resterilize. If the product is reused the performance of the product may deteriorate, and cross contamination may occur which may lead to infection.
- SURGIFLO™ Hemostatic Matrix is supplied as a sterile product. Unused open SURGIFLO™ Hemostatic Matrix should be discarded. Do not use SURGIFLO™ Hemostatic Matrix if sterile barrier package is damaged as sterility may be compromised.
- While packing a cavity for hemostasis is sometimes surgically indicated, SURGIFLO™ Hemostatic Matrix should not be used in this manner unless excess product that is not needed to maintain hemostasis is removed. When incorporated into a fibrin clot, SURGIFLO™ Hemostatic Matrix may swell up to 20% upon contact with additional fluid.
- SURGIFLO™ should not be used in conjunction with autologous blood salvage circuits.
- SURGIFLO™ should not be used in conjunction with methylmethacrylate adhesives.
- In urological procedures, SURGIFLO™ should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
ADVERSE EVENTS
A total of 142 patients received SURGIFOAM™ Sponge during a clinical trial comparing SURGIFOAM™ Sponge to another absorbable gelatin sponge. In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:
- Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial growth.
- Giant cell granulomas have been observed at implant sites when used in the brain.
- Compression of the brain and spinal cord resulting from the accumulation of sterile fluid have been observed.
- Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.
- The use of absorbable gelatin-based hemostatic agents during the repair of dural defects associated with laminectomy and craniotomy operations, has been associated with fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and paresis.
- The use of absorbable gelatin-based hemostatic agents has been associated with paralysis, due to device migration into foramina in the bone around the spinal cord, and blindness, due to device migration in the orbit of the eye, during lobectomy, laminectomy, and repair of a frontal skull fracture and lacerated lobe.
- Foreign body reactions, “encapsulation” of fluid, and hematoma have been observed at implant sites.
- Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin-based sponges were used in severed tendon repair.
- Toxic shock syndrome was reported in association with the use of absorbable gelatin-based hemostats in nasal surgery.
- Fever, failure of absorption, and hearing loss have been observed when absorbable hemostatic agents were used during tympanoplasty.
Adverse Reactions to Gelatin-Based Hemostatic Agents with Thrombin
Adhesion formation and small bowel obstruction are well-known and common complications following abdominal and gynecological surgeries. Adverse events such as these, as well as inflammation and foreign body reaction including giant cell granulomas, have been reported within abdominal and gynecological surgeries in which gelatin-based and collagen-based hemostatic agents with thrombin have been used in excessive amount. Inflammation and foreign body reaction such as encapsulation of the product may mimic artifacts on radiographic images, resulting in diagnostic errors and possible reoperation. Therefore, as with other gelatin hemostatic agents, only the minimum amount of SURGIFLO™ Hemostatic Matrix needed to achieve hemostasis should be used. Once hemostasis is achieved, any excess SURGIFLO™ Hemostatic Matrix should be carefully removed.
EVITHROM™ Thrombin, Topical (Human) for Topical Use Only Lyophilized Powder for Solution EVITHROM™ is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM™ may be used in conjunction with an Absorbable Gelatin Sponge, USP.
Important Safety Information
- For topical use only.
- Do not inject.
- Apply EVITHROM™ on the surface of bleeding tissue only.
- The amount of EVITHROM™ required depends upon the area of tissue to be treated and the method of application. In clinical studies, volumes up to 10 ml were used in conjunction with Absorbable Gelatin Sponge.
- Do not use for the treatment of severe or brisk arterial bleeding.
- Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. Hypersensitivity reactions, including anaphylaxis, may occur.
- There is a potential risk of thrombosis if absorbed systemically.
- May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of viral transmission.
- The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM™) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time, and increased neutrophil count.
- None of the patients treated with EVITHROM™ developed antibodies to human thrombin or to human Factor V/Va. The clinical significance of these findings is unknown.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
US_ETH_BIOS_111036.1
EVARREST™ Fibrin Sealant Patch Important Safety Information
Indications and Usage
EVARREST™ is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
Limitations for Use
• Cannot be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding.• Not for use in children under one month of age
• Laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve.
Dosage and Administration
For topical use only
• Determine the number of patches to be applied based upon the surface area and anatomic location of the bleeding tissue to be treated.
• Keep the patch dry until use.
• Place the powdery (active) side of the patch on the surface of tissue.
• Apply immediate manual compression over the entire surface of the patch and maintain contact pressure for 3 minutes to control the bleeding.
Dosage Forms and Strengths
EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component. The active side is powdery, and the non-active side has an embossed wave pattern.
Each 2 x 4 inch (5.1 x 10.2 cm) absorbable patch contains:
• 55.5 mg per square inch (8.6 mg per square cm) human fibrinogen
• 241.9 Units per square inch (37.5 Units per square cm) human thrombin
Contraindications
• Do not use to treat bleeding from large defects in arteries or veins.
• Do not apply intravascularly.
• Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
Warnings and Precautions
• Thrombosis can occur if absorbed systemically. Apply topically to the bleeding site only.
• Can cause hypersensitivity reactions including anaphylaxis.
• Avoid application to contaminated areas of the body or in the presence of active infection. Infection can occur.
• EVARREST™ contains oxidized regenerated cellulose which adheres to bleeding surfaces. Inadvertent adhesions can occur.
• Avoid use in, around, or in proximity to, foramina in bone or areas of bony confine where swelling may cause compression.
• Use the least number of patches required to cover the entire bleeding area.
• May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse Reactions
The adverse reactions reported during clinical trials occurred in less than 1% of all cases and included deep venous thrombosis, pulmonary embolism, blood fibrinogen increase, anastomotic hemorrhage, post procedural and intra-abdominal hemorrhage, abdominal distension, anemia, gastrointestinal hemorrhage, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, localized intra-abdominal fluid collection, cardiac failure, operative hemorrhage, and ischemic bowel.
To report SUSPECTED ADVERSE REACTIONS, contact ETHICON Customer Support Center at 1-877-384-4266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pediatric: Use in children under the age of one month may be unsafe or ineffective due to small size and limited ability to apply the patch as recommended.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
US_SRG_BIOS_125120.1
VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
INDICATION
VISTASEAL™, a fibrin sealant, is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL™ is effective in heparinized patients.
CONTRAINDICATIONS
Do not inject directly into the circulatory system.
Do not use for the treatment of severe or brisk arterial bleeding.
Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.
Do not use VISTASEAL™ for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.
WARNINGS AND PRECAUTIONS
Thromboembolic events may occur if VISTASEAL™ is administered intravascularly.
Hypersensitivity reactions can occur.
May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
ADVERSE REACTIONS
The most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
US_ETH_BIOS_110059.2
A. US market leadership measured in unit volume.
B. SURGIFLO™ Hemostatic Matrix Kit with Thrombin was evaluated in a double-blind qualitative market research study of 40 surgeons from a variety of specialties.
C. Compared to SURGIFLO™ 2994 Hemostatic Matrix Kit with Thrombin and Floseal with Recothrom
D. SURGIFLO™ Hemostatic Matrix Kit with Thrombin was evaluated in a double-blind qualitative market research study of 40 surgeons from a variety of specialties.
E. P=0.0016
F. In a large retrospective nationwide hospital database assessing SURGIFLO™ and Floseal in a spine surgery population.
G. In a retrospective study of 28,910 spinal surgery patients from the Premier Healthcare Database.
H.P=0.0001.
I. In animal models.
J. Based on in vitro viscosity testing of SURGIFLO™ 8 mL and FLOSEAL Hemostatic Matrix 5 mL; each product was prepared following Instructions for Use.
K. Compared to Floseal with Recothrom
L. Compared to previous SURGIFLO™ version
- Ethicon U.S. Market Share Biosurgery Report, Year-to-Date, December, 2022. Ethicon, Inc.
- Ethicon U.S. Diagnosis Related Group Sales Report, 2022. Ethicon, Inc.
- Valls Palleja M, Almazan del Castillo R, Fernandez Soto R, et al. Systematic revision and meta-analysis of gelatin-thrombin hemostatic matrices for bleeding control. Presented at ISPOR 21st Annual International Meeting. Washington, DC. 2016.
- SURGIFLO™ vs Floseal + Recothrom Qualitative Research. October 4, 2023. Ethicon, Inc
- Ferrosan Medical Devices. Time Motion Study Report SF2995. 3/10/2025.
- Valls M, Almazan R, Fernandez, Gay JG, Zanela OO, et al. Systematic revision and meta‐analysis of hemostatic matrices for bleeding control. Poster. Mexico City, Mexico. 2016
- Danker W, Kelkar SS, Marston XL, Aggarwal J, Johnston SS. Real-world economic and clinical outcomes associated with current hemostatic matrix use in spinal surgery. J Comp Eff Res. 2022; 11(17):1231-1240. doi: 10.2217_cer-2021-0218.
- Danker W, Marston X, Aggarwal J, Johnston S. Real-world economic and clinical outcomes associated with current hemostatic matrix use in spinal surgery. Presented at Virtual ISPOR 2020 Conference, May 18-20, 2020. Ethicon, Inc.
- Ethicon, Inc. Pilot evaluation comparing the time‐to‐ hemostasis and hemostatic efficacy of Surgiflo™, next generation Surgiflo™, and Floseal (all prepared with thrombin) in an acute punch biopsy porcine spleen model: Final report 11‐071. June 7, 2011.
- HUTCHINSON RICHARDW, WERRLEIN STEPHANIE, JOHNS DOUG, ZHANG GARY, CLYMER JEFFREY, KOCHARIAN RICHARD. An In Vivo Comparison of Hemostatic Gelatin Matrix Products in a Porcine Spleen Biopsy‐punch Model. SURGICAL TECHNOLOGY INTERNATIONAL . XXVII.
- Gazzeri, R. et al. Use of a Thrombin-Gelatin Haemostatic Matrix (Surgiflo) in Spinal Surgery. Surgical Technology International XXV, 2014.
- Gazzeri R, Galarza M, Alfier A. The Safety and Biocompatibility of Gelatin Hemostatic Matrix (FLOSEAL and Surgiflo) in Neurosurgical Procedures. Surg Technol Int. 2012;22:1-6.
- Wang, A. Measurements of Viscosity and Thrombin Activity of SURGIFLO 2993 as Compared to FLOSEAL Over Time. Technical Report, April 7, 2013. Ethicon, Inc.
- Ferrosan Medical Devices. SURGIFLO SF2995 Waste Claims Report. July 23, 2025.
- Zhang, G. Gelatin Paste Density in SURGIFLO Next Generation Product. Technical Report, March 3, 2011. Ethicon, Inc.
- Werrlein, S. Evaluation of the Conformability of SURGIFLO (Pre-filled Flowable Hemostat), vs. SURGIFOAM Absorbable Gelatin Sponge, PSE Accession No. 04-0624, Project No. 67314, December 10, 2004, Ethicon, Inc.
- Changes in SURGIFLO™ Hemostatic Matrix. Memo-Ferrosan Medical Devices. January 25, 2011. Ethicon, Inc.
- Report, Evaluation of the Hemostatic Efficacy of SURGIFLO (Pre-filled Flowable Hemostat) Plus Thrombin Compared to FloSeal Kit. Feb 10, 2005.
- Report, Evaluation of the Conformability of SURGIFLO (Pre-filled Flowable Hemostat), vs SURGIFOAM Absorbable Gelatin Sponge. Dec 10, 20
The third-party trademarks used herein are trademarks of their respective owners.
© Johnson & Johnson and its affiliates 2026. US_SRG_BIOS_131297.2
US_ETH_BIOS_390927