STRATAFIX™ Knotless Tissue Control Devices

Why Knot?

Don't compromise - choose STRATAFIX™ The self-anchoring technology of the STRATAFIX™ provides multiple points of fixation along the suture line, combining the strength and security of interrupted closure with the e�iciency of continuous closure – with no knot-related complications, such as increased risk of infection from bacterial attachment.1-3,7

STRATAFIX™ provides more strength, more security, and more e�iciency than traditional suturing, with protection against infection risk1-6*

Anchor technology locks into position with each pass and prevents loosening of the device

More strength* and security compared to interrupted suturing, with no knot-related complications1,3,7-9

• STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices provide 39% greater holding strength than coated VICRYL® (polyglactin 910) Suture1

• STRATAFIX Symmetric PDS Plus Device is the only barbed sutureappropriate for closing high-tension areas such as fascia1, 10

• In pre-clinical studies using STRATAFIX Knotless Tissue Control Devices for wound closure, multiple cuts to the device did not result in separation of the approximated tissue edges3,11

STRATAFIX™ Knotless Tissue Control Devices

Get more from your suture Give more to your patients

Protection from infection risk• STRATAFIX Knotless Tissue Control Devices with IRGACARE MP (triclosan) are the only commercially

available knotless tissue control devices with antibacterial protection4,5*

• Meta-analysis demonstrates 28% reduction in SSI risk with the use of triclosan-coated sutures13†‡§

• No knot-related infection risks

- Knots serve as additional sites for bacterial attachment14

• Three globally recognized health authorities now recommend the use of triclosan-coated sutures for SSI prevention

*Refers only to STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device, STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

†In a meta-analysis that included 21 RCTs, 6462 patients, 95% CI: (14, 40%), P<0.001.‡All triclosan-coated sutures in these RCTs were Ethicon Plus Antibacterial Sutures (MONOCRYL Plus Suture, VICRYL Plus Suture, and PDS Plus Suture).§Meta-analysis only included traditional (non-barbed) sutures¶In an animal model

||CDC, WHO, and ACS/SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.

Centers for DiseaseControl and Prevention(CDC)

World Health Organization (WHO) American College of Surgeons& Surgical Infection Society

Consider the use of triclosan-coated suturesfor the prevention of SSI.15||

The panel suggests the use oftriclosan-coated sutures for the purpose of reducing the risk of SSI, independent of the type of surgery.16||

Triclosan antibacterial suture useis recommended for wound closurein clean and clean-contaminatedabdominal cases when available.17||

More e�iciency and consistency compared with traditional sutures• STRATAFIX Knotless Tissue Control Devices can close wounds substantially faster than using

an interrupted technique1,3,7,9,11

• Compared with traditional sutures, STRATAFIX Knotless Tissue Control Devices allow surgeons to easily manage tension and control approximation during closure2,3,7

• STRATAFIX™ Spiral Knotless Tissue Control Devices (bidirectional) improve e�iciency by allowing 2 clinicians to close at the same time with a single device

*Refers to STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device only.STRATAFIX™ with Antibacterial Technology (triclosan) are proven in vivo to kill bacteria on the suture associated with SSIs4,5,18¶

Benefits beyond the OR

0 12%reduction in rate of discharge to a skilled nursing facility12†24% reduction in surgical site infection

(SSI) risk with the use of triclosan-coated sutures13‡§||

Meta-analysis demonstrated

28%

knot-related complications reduction in lengthof stay (days)12†

The petri dish images are for illustrative purposes only, zone of inhibition testing results can vary.

†In a retrospective, observational study of 5958 patients.‡In a meta-analysis that included 21 RCTs, 6462 patients, 95% CI: (14, 40%), P<0.001.§All triclosan-coated sutures in these RCTs were Ethicon Plus Antibacterial Sutures (MONOCRYL Plus Suture, VICRYL Plus Suture, and PDS Plus Suture).||Meta-analysis only included traditional (non-barbed) sutures.

#1 market leader in barbed suture technology19

Comprehensive portfolio features a wide range of sizes, lengths, and needle types, including those appropriate for open, laparoscopic, and robotic procedures.

• Short-term, long-term, and non-absorbable polymers

• Superior Ethicon needles provide exceptional strength and penetration20,21

• Created by Ethicon – trusted for wound closure innovation with proven outcomes for 130 years

©2019 Ethicon US, LLC. All rights reserved. 109499-190314

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

References: 1. Nonnenman H. 100326296: Time zero tissue holding - Competitive claims comparisons for STRATAFIX Knotless Tissue Control Devices vs various products. 2015. Ethicon, Inc. 2. 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. 3. 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. 4. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial e�icacy of PDS Plus (polidioxanone with triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451-457. 5. Ming X, Rothenburger S, Yang D. In vitro antibacterial e�icacy of Monocryl Plus Antibacterial Suture (poligelcaprone 25 with triclosan). Surg Infect (Larchmt). 2007;8(2):201-207. 6. Rothenburger S, Spangler D, Bhende S, Burkley D. In vitro antimicrobial evaluation of coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt). 2002;3 Suppl 1:S79-S87. 7. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928/01477447-20110714-35. 8. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and e�icacy. J Minim Invasive Gynecol. 2011;18(1):92-95. 9. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167. 10. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Instructions for Use. Ethicon, Inc. 11. Overaker D. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitching patterns. AST-2012-0331. August 24, 2012. Ethicon, Inc. 12. Johnston S, Sutton N. Retrospective, observational study using the Premier® Perspective Hospital Database. Stratafix & Prineo Study. 2017. Ethicon, Inc. 13. 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. 14. Kathju S, Nistico L, Lasko L-A, et al. Bacterial biofilm on monofilament suture and porcine xenograft after inguinal herniorrhaphy. FEMS Immunol Med Microbiol. 2010;59:405-409. 15. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection. 2017. JAMA Surg. 2017;153(8):784-791. 16. WHO Global Guidelines for the Prevention of Surgical Site Infection, 2016. 17. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2016;224(1):59-74. 18. Storch ML, Rothenburger S, Jacinto G. Experimental e�icacy study of coated VICRYL plus antibacterial suture in guinea pigs challenged with Staphylococcus aureus. Surg Infect (Larchmt). 2004;5(3):281-288. 19. Joshi P. Wound closure market and share October 2018 update. January 2019. Ethicon, Inc. 20. Technical Memo CT12-009. December 12, 2012. Ethicon, Inc. 21. Technical Memo CT09-022. January 20, 2010. Ethicon, Inc.

Two innovative anchor designs provide versatility and a unique combination of benefits

Tissue TypeHealing

Time

STRATAFIX™ Symmetric PDS™ Plus Knotless TissueControl Device

STRATAFIX™ Spiral MONOCRYL™Plus Knotless TissueControl Device

STRATAFIX™ Spiral PDS™ PlusKnotless TissueControl Device

STRATAFIX™ Spiral PolypropyleneKnotless TissueControl Device

Skin (subcuticular) 1-2 weeks

Fat (subcutaneous) 1-2 weeks

Fascia 3+ weeks

Deep Tissue

(muscle)4-6 weeks

Organ Varies

Hernia Mesh N/A

STRATAFIX Symmetric PDS Plus Device

The only barbed suture appropriate for closing high-tension areas such as fascia1,10

STRATAFIX™ Spiral Knotless Tissue Control Devices

A broad range of unidirectional and bidirectional devices o�ers the smooth glide of a traditional suture