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STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device Exceptional wound-closure strength for a variety of open, laparoscopic, and robot-assisted procedures 1-4 Stratafix Now available in 60+ codes The third-party trademarks used herein are trademarks of their respective owners. *Than traditional sutures Get more with the STRATAFIX™ Knotless Tissue Control Devices portfolio 1-10 More security * More consistency * More efficiency *

STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic

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Page 1: STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DeviceExceptional wound-closure strength for a variety of open, laparoscopic, and robot-assisted procedures1-4

Stratafix™ Now available in 60+ codes

The third-party trademarks used herein are trademarks of their respective owners.

*Than traditional sutures

Get more with the STRATAFIX™ Knotless Tissue Control Devices portfolio1-10

• More security*

• More consistency*

• More efficiency*

Page 2: STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic

6” (15 cm) | 9” (23 cm) | 12” (30 cm) | 18” (45 cm) | 24” (60 cm)

Why is a strong fascial closure important?

Following surgery, fascial wounds are self-supportive by 14-28 days post-op—however, a strong fascial closure is critical for preventing wound complications during healing12,13:

• Dehiscence occurs in up to 3.5% of midline incisions14

• Surgical site infections (SSIs) occur in up to 19% of midline incisions13,15-17

• Incisional hernia occurs in up to 23% of midline incisions15,17

Expanded Portfolio for Greater Versatility

The only barbed suture appropriate for closing high-tension areas, such as fascia1,11

• 39% stronger in fascia than Coated VICRYL® (polyglactin 910) Suture (interrupted technique)1

• 25% stronger in fascia than Looped PDS® II (polydioxanone) Suture (continuous technique)1

• 15% stronger in subcutaneous tissue than V-Loc™ 180 Absorbable Wound Closure Device which is made from Maxon™ Suture 1

Only barbed suture with the exceptional strength needed to close high-tension areas such as fascia1,11

The IFU for V-Loc™ 180 Device includes a warning against use in fascia18

Multiple lengths for application in laparoscopic, robot-assisted, and open procedures across a variety of specialties

Specialty Procedure

GYN Hysterectomy, Myomectomy

Bariatric Sleeve Gastrectomy

General Surgery Hernia Repair

Lap/Robotic Open

Specialty Procedure

Orthopaedics TKA, THA, Spine

Plastics Abdominoplasty

OB/GYN C-section, Hysterectomy, Myomectomy

General Surgery Laparotomy Closure, Hernia Repair, Colorectal

(Note: This is a representation of scale; lengths shown here are shorter than true lengths)

129.5

103.7993.42

STRATAFIXSymmetric PDS

Plus Device

LoopedPDS

VicrylInterrupted

Max

Loa

d (m

ean

)

P=0.009

Superior tissue-holding strength

39% greater thaninterrupted Coated VICRYL®

25% greater thanLooped PDS

Page 3: STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic

One-piece core construction preserves tensile strength

Greater long-term strength retention

Premium Ethicon needlesAll STRATAFIX™ Knotless Tissue Control Devices are paired with Ethicon needles

• Superior penetration and strength compared to V-Loc™ and Quill™ needles19,20

• Resistant to bending and breaking

• Penetrate tissue smoothly

Pen

etra

tio

n F

orc

e (g

ram

s)

Pass

MEDTRONIC, GS-21

ETHICON, CT-1

PENETRATION FORCE COMPARISON

GOOD

300

250

200

150

100

50

011 02 03 0

Torq

ue

(gra

m •

cm)

Angle (degrees)

QUILL, DE-12, 22 mil

ETHICON, STRATAFIX FS-2, 24 mil

STRENGTH COMPARISON

GOOD

1200

1000

800

600

400

200

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices provide 6 weeks extended wound-holding support while Medtronic’s V-Loc™ 180 Device, which is made from Maxon™ Suture, provides only 3 weeks of support11,18

MEDTRONIC, V-LOC 180 Device

ETHICON, STRATAFIX Symmetric PDS Plus Device

% S

tren

gth

Ret

enti

on

Days Implantation

90

80

70

60

50

7 14 21 28 35 42

% STRENGTH RETENTION

Attached to Ethicon needles

Pressed symmetrical anchors maintain the core of the device, providing exceptional holding strength11

STRATAFIX Symmetric PDS Plus Device technique provides greater initiation strength of the closure compared to PDS® Plus Antibacterial (polydioxanone) Suture 5-throw knot tower2

Core

Page 4: STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic

Take greater control of key risk factors related to Surgical Site Infections (SSIs)

STRATAFIX™ Knotless Tissue Control Devices are the only commercially available barbed sutures with antibacterial protection

Bacterial colonization is a potential complication of suture knots and braided sutures.24

SSIs occur in up to 19% of midline incisions and can begin anywhere, from the skin to deep tissues13,15-17

• Can increase the risk of dehiscence and incisional hernia13

• Extend the inflammatory phase, during which the tissue has essentially no strength24

• Bacterial colonization of the suture is a known risk factor for SSI24

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

V-Loc™ Wound Closure Device

17 days against E. coli 23 days against S. aureus

0 days against E. coli0 days against S. aureus

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

BACTERIAL GROWTH

Exclusive to Ethicon, Plus Antibacterial Technology is shown in vitro to inhibit colonization of the suture for 7 days or more—to address a known risk factor for SSI25-27

Triclosan-Coated Sutures are now supported by:

Page 5: STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic

Expanded portfolio to meet your closure needs in a variety of procedures and tissue typesA variety of lengths, sizes, and needle types to meet your specific wound closure needs

NeedleLength

(in) (cm)3-0 2-0 0 1

17 mm, 1/2 Circle, Taper Point, RB-1612

1530

SXPP1A411SXPP1A427

19 mm, 3/8 Circle, Reverse Cutting, PS-2 18 45 SXPP1A101

22 mm, 1/2 Circle, Taper Point, SH-1 12 30 SXPP1A430

24 mm, 3/8 Circle, Reverse Cutting, PS-1 18 45 SXPP1A100

26 mm, 1/2 Circle, Taper Point, SH

691218

15233045

SXPP1A413

SXPP1A428SXPP1A410

SXPP1A414SXPP1A421SXPP1A431SXPP1A409

26 mm, 1/2 Circle, Taper Point, CT-26918

152345

SXPP1A415SXPP1A422SXPP1A408

SXPP1A446SXPP1A407

SXPP1A419

26 mm, 5/8 Circle, Taper Point, UR-6 6 15 SXPP1A417 SXPP1A447

26 mm, 1/2 Circle, Tapercut®, V7 9 23 SXPP1A424

Total number of codes

Suture sizes

Suture lengths

Needle lengths

Paired with Ethicon’s premium needles

63

• 3-0• 2-0• 0• 1

• 6” (15 cm)• 9” (23 cm) • 12” (30 cm) • 18” (45 cm) • 24” (60 cm)

17 mm−48 mm

• Reverse Cutting• Taper Point • Tapercut® • Ethiguard® Safety Needle

More length options for greater versatility in laparoscopic, robot-assisted, and open procedures

Page 6: STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic

©2018 Ethicon US, LLC. All rights reserved. 090504-180420

For more information, contact your Ethicon representative or call 1-877-ETHICON.For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

References: 1. Nonnenmann H. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015. Ethicon, Inc. 2. Nonnenmann H. Performance Testing of STRATAFIX SYMMETRIC PDS PLUS Size 3-0, 0, and 1 – Initiation Strength in Porcine Tissue. AST-2013-0603. April 11, 2018. Ethicon, Inc. 3. Nonnenmann H. Ethicon Performance Evaluation Memo AST-2012-0510. Performance Testing of STRATAFIX Symmetric Size 2-0 suture device for Tissue Holding Strength with an Incision Defect to Measure Gapping. Dated December 3, 2012. Ethicon, Inc. 4. Nonnenmann H. AST-2013-0056 Performance Testing of STRATAFIX Symmetric PDSSize2-0 suture device for Tissue Holding Strength with Multiple Incision Defects to Measure Gapping. April 4, 2013. Ethicon, Inc. 5. 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. 6. Vakil JJ, O’Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713. 7. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167. 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 efficacy. J Minim Invasive Gynecol. 2011;18(1):92-95. 9. 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. 10. Overaker D. Ethicon study AST-2012-0331. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitching patterns. Approved on August 24, 2012. Ethicon, Inc. 11. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Instructions for Use. Ethicon, Inc. 12. Ethicon Wound Closure Manual. 2007. Ethicon, Inc. 13. Dubay DA, Franz MG. Acute wound healing: the biology of acute wound failure. Surg Clin North Am. 2003;83:463-481. 14. van Ramshorst GH, Nieuwenhuizen J, Hop WC, et al. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010;34(1):20-27. 15. Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009;144(11):1056-1059. 16. Petrosillo N, Drapeau CM, Nicastri E, et al; ANPIO. Surgical site infections in Italian hospitals: a prospective multicenter study. BMC Infect Dis. 2008;8:34. 17. Seiler CM, Bruckner T, Diener MK, et al. Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541). Ann Surg. 2009;249(4):576-582. 18. V-Loc™ 180 Absorbable Wound Closure Device Instructions for Use. Medtronic. 19. Technical Memo CT12-009. December 12, 2012. Ethicon, Inc. 20. Technical Memo CT09-022. January 20, 2010. Ethicon, Inc. 21. 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. doi:10.1001/jamasurg.2017.0904. 22. Global guidelines on the prevention of surgical site infection. World Health Organization website. http://www.who.int/gpsc/ssi-prevention-guidelines/en/. Accessed December 29, 2017. 23. 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;224:59-74. 24. Edmiston CE, Seabrook GR, Goheen MP, et al. Bacterial adherence to surgical sutures: can antibacterial-coated sutures reduce the risk of microbial contamination? J Am Coll Surg. 2006;203:481-489. 25. 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):451-457. 26. 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):S79-S87. 27. 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):201-207.

NeedleLength

(in) (cm)3-0 2-0 0 1

26 mm, 1/2 Circle, Reverse Cutting, CP-2 18 45 SXPP1A437

36 mm, 1/2 Circle, Reverse Cutting, OS-6

1824

4560

SXPP1A200SXPP1A202

SXPP1A201SXPP1A203

36 mm, 1/2 Circle, Taper Point, CT-1

69121824

1523304560

SXPP1A429SXPP1A438

SXPP1A416SXPP1A423SXPP1A432SXPP1A403SXPP1A439

SXPP1A418SXPP1A425SXPP1A433SXPP1A401SXPP1A440

SXPP1A420

SXPP1A435SXPP1A404SXPP1A443

36 mm, 1/2 Circle, Taper Point, Ethiguard® Safety Needle, CTB-1

1824

4560 SXPP1A303

SXPP1A301SXPP1A304

36 mm, 1/2 Circle, Tapercut®, V-34 9 23 SXPP1A426

40 mm, 1/2 Circle,Taper Point, CT

121824

304560

SXPP1A412SXPP1A406SXPP1A441

SXPP1A405SXPP1A444

40 mm, 1/2 Circle, Reverse Cutting, OS-8

24 60 SXPP1A204 SXPP1A205

48 mm, 1/2 Circle,Taper Point, CTX

121824

304560

SXPP1A434SXPP1A402SXPP1A442

SXPP1A436SXPP1A400SXPP1A445

48 mm, 1/2 Circle, Taper Point, Ethiguard® Safety Needle, CTXB

1824

4560

SXPP1A302SXPP1A305

SXPP1A300SXPP1A306