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STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y,...
Transcript of STRATAFIX Symmetrci PDS Plus Knotless Tissue Control Device · Einarsson JI, Chavan NR, Suzuki Y,...
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*
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
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
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:
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
©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