*SURGIFLO^® with thrombin achieved hemostasis in less than a minute in an animal model.⁴

†STRATAFIX™ Plus Knotless Tissue Control Devices provide more efficiency, consistency, security, and strength (STRATAFIX™ SYMMETRIC™ Knotless Tissue Control Device), than traditional suturing while addressing a known risk factor for surgical site infection.^6-11 

‡DERMABOND^® PRINEO^® Skin Closure System may reduce time to close the final layer of skin by as much as 84%.^15,16

§Compared to 10 mL FLOSEAL Hemostatic Matrix.

||In a retrospective study of 28,910 spinal surgery patients between 1/1/2013-06/1/2018 from the Premier Healthcare Database. 

¶P=0.0152, 0.0007, and <0.0001, respectively.

#In spinal fusion and laminectomy procedures, using STRATAFIX™ Knotless Tissue Control Devices is associated with significantly shorter time spent in the OR and lower costs compared to traditional sutures. Based on a retrospective analysis of 7,410 spinal fusion and laminectomy procedures from the Premier Perspective^® Hospital Database, using STRATAFIX barbed sutures was associated with lower OR time (P=0.015) and costs (P=0.02) than traditional sutures.²³

**Only applies to STRATAFIX™ Symmetric PDS™ Plus, STRATAFIX™ Spiral PDS™ Plus, and MONOCRYL^® Plus. 

††In vitro studies comparing STRATAFIX™ Symmetric PDS™ Plus vs. V-Loc™ 180, and comparing STRATAFIX™ Spiral MONOCRYL™ Plus vs. V-Loc™ 90.

 ‡‡Creates a watertight seal, creating a barrier to water and bacteria entering the wound.^17,21

§§In an ex-vivo study, more load in N was required to create a 3 ±1 mm gap between skin edges approximated with DERMABOND PRINEO System, than with subcuticular 4-0 MONOCRYL Suture or PROXIMATE^® Ethicon Endo-Surgery skin staples (P=0.00).

||||In a retrospective, observational study using the Premier Healthcare Database in total knee arthroplasty (N=1,942), 2012-2015; LOS 2.8 days vs 3.2, P=0.002; discharge to SNF 26% vs 39%, P=0.011; 30-day readmissions 1.8 vs 4.4%, P=0.006).

¶¶Compared to 10 mL FLOSEAL Hemostatic Matrix.

##Refers to STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device only.

***Only applies to STRATAFIX™ Symmetric PDS™ Plus, STRATAFIX™ Spiral PDS™ Plus, and MONOCRYL^® Plus.

1. SURGIFLO^® Hemostatic Matrix Kit (2994) Instructions for Use. Ethicon, Inc. 

2. FLOSEAL Hemostatic Matrix Instructions for Use. Baxter Healthcare. 

3. Johns D, Metzler B. Comparison of thrombin reconstitution time in SURGIFLO^® Hemostatic Matrix Kit with Thrombin and Floseal^® Hemostatic Matrix Kit. 11052017. February 9, 2017. Ethicon, Inc. 

4. Langkilde, S. Evaluation of the dose response curve for Hemostatic Efficacy of Surgiflo Next Generation mixed with Thrombin. 2013;Report NG-162. Ethicon, Inc. 

5. 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. 

6. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178. 

7. Vakil JJ, O'Reilly MP, Sutter EG, Mears SC, Belko SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713. 

8. Nawrocki J. Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 100326296. May 20, 2015. Ethicon, Inc. 

9. de Jonge SW, Atema JJ, Solomkin JS, Boermeester MA. Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical-site infection. Br J Surg. 2017;104(2):e118-e133. 

10. Ming X, Rothenburger S, Yang D. In vitro antibacterial efficacy of Monocryl Plus Antibacterial Suture (poligelcaprone 25 with triclosan). Surg Infect (Larchmt). 2007;8(2):201-07. 

11. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficacy of PDS Plus (polidioxanone with triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451-57. 

12. Bhende S, Burkley D, Nawrocki J. In vivo and in vitro antibacterial efficacy of absorbable barbed poydioxanone monofilament tissue control device with triclosan. Surg Infect. 2018; Volume 19 (4):430-437. 

13. Bhende S. Competitive assessment: Comparative evaluation of bacterial colonization on STRATAFIX™ Symmetric PDS Knotless Tissue Control Device vs. V-Loc™ 180 Absorbable Wound Closure Device using attachment assay and scanning electron microscopy (SEM). AST-2019-0210. November 13, 2019. Ethicon, Inc. 

14. Bhende S. Study Report: Comparative evaluation of bacterial colonization on STRATAFIX Spiral MONOCRYL Plus Knotless Would Closure Device vs V-LOC 90 Absorbable Wound Closure Device and MONOCRYL knots using an in vitro attachment assay and scanning electron microscopy. October 12, 2018. Ethicon, Inc. 

15. Thomson CM. Multi-centre study to show equivalence of DERMABOND PROTAPE to INTRADERMAL SUTURES for skin closure of full thickness surgical incisions associated with breast procedures. 07CS003. July 9, 2010. Ethicon, Inc. 

16. Thomson CM. Multi-centre study to show equivalence of DERMABOND PROTAPE to INTRADERMAL SUTURES for skin closure of full thickness surgical incisions. 06CS005. June 10, 2010. Ethicon, Inc. 

17. Kumar A. Completion Report: Study to compare the tissue holding strength of PRINEO™ skin closure system with conventional wound closure techniques. AST-2012-0290. October 11, 2012. Ethicon, Inc. 

18. Sutton N, Schmitz ND, Johnston SS. Economic and clinical comparison of 2-octyl cyanoacrylate/polymer mesh tape with skin staples in total knee replacement. J Wound Care. 2018;27(Sup4):S12-S22. 

19. Barbolt TA. Chemistry and safety of triclosan, and its use as an antimicrobial on Coated VICRYL* Plus Antibacterial Suture (coated polyglactin 910 suture with triclosan). Surg Infect (Larchmt). 2002;3(suppl1):S45-S53. 

20. Keplinger S. Protocol investigation of the comparison of PRINEO with conventional wound closure techniques. Protocol 07PD048. May 15, 2007. Ethicon, Inc. 

21. DERMABOND^® PRINEO^® Skin Closure System Instructions for Use. Ethicon, Inc. Shapiro A, Dinsmore R, North J, Tensile strength of wound closure with cyanoacrylate glue. Am Surg. 2001;67:1113-1115. 

22. Kannon GA, Garrett AB. Moist wound healing with occlusive dressings. Dermatol Surg. 1995;21:583-590.  

23. Johnston S, Chen B, Tommaselli G, Jain S, Pracyk J. Barbed and conventional sutures in spinal surgery patients: an economic and clinical outcomes comparison. J Wound Care. 2020;29(5):S9-S20.
 

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.

021328-180430

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

• 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.

WARNINGS

• 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. 

PRECAUTIONS

• 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^® is supplied as a sterile product and cannot be resterilized. 

• SURGIFLO^® should not be used for packing unless excess product that is not needed to maintain hemostasis is removed. SURGIFLO^® 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.

063756-161128

SURGIFLO^® Hemostatic Matrix Essential Product Information (Made from Absorbable Gelatin Sponge, USP) 

DESCRIPTION

SURGIFLO^® Hemostatic Matrix is intended for hemostatic use by applying to a bleeding surface.

ACTIONS

When used in appropriate amounts SURGIFLO^® Hemostatic Matrix is absorbed completely within 4 to 6 weeks. 

INTENDED USE/INDICATIONS

SURGIFLO^® Hemostatic Matrix , mixed with with sterile saline  or 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^® Hemostatic Matrix in intravascular compartments because of the risk of embolization.

• Do not use SURGIFLO^® Hemostatic Matrix in patients with known allergies to porcine gelatin.

• Do not use SURGIFLO^® Hemostatic Matrix 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.

WARNINGS

• SURGIFLO^® Hemostatic Matrix should not be used in the presence of infection and should be used with caution in contaminated areas of the body

• SURGIFLO^® Hemostatic Matrix should not be used in instances of pumping arterial hemorrhage SURGIFLO^® Hemostatic Matrix will not act as a tampon or plug in a bleeding site.

• SURGIFLO^® Hemostatic Matrix 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^® Hemostatic Matrix should be removed once hemostasis has been achieved.

• The safety and effectiveness of SURGIFLO^® Hemostatic Matrix for use in ophthalmic procedures has not been established.

• SURGIFLO^® Hemostatic Matrix should not be used for controlling post-partum intrauterine bleeding or menorrhagia.

• The safety and effectiveness of SURGIFLO^® Hemostatic Matrix 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. 

PRECAUTIONS

• 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 supplied as a sterile product and cannot be resterilized. 

• SURGIFLO^® Hemostatic Matrix should not be used for packing unless excess product that is not needed to maintain hemostasis is removed. SURGIFLO^® Hemostatic Matrix may swell up to 20% upon contact with additional fluid.

• SURGIFLO^® Hemostatic Matrix should not be used in conjunction with autologous blood salvage circuits. 

• SURGIFLO^® Hemostatic Matrix should not be used in conjunction with methylmethacrylate adhesives. 

• In urological procedures, SURGIFLO^® Hemostatic Matrix 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.

064302-200513