Intended for healthcare professionals

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

STRATAFIX™ Portfolio offers a variety of barbed sutures, polymers, and undirectional and bidirectional designs to accommodate a wide variety of procedures. View device specifications for full portfolio offering.


With a unique anchor design, STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is the only barbed suture appropriate for high-tension areas, such as fascia.1,2A It is a next generation suture device that eliminates the need for knot-tying or need for an assistant to follow the suture.3,4 Fixating barbs allow tension to be maintained on each pass for more security, consistency, and efficiency than traditional sutures.1,5-12 In addition, STRATAFIX™ Devices are the only antibacterial barbed suture available worldwide.13B

Contact repDevice specifications
Stratafix being held by a tool with a needle
Stratafix strand laid out in a swirl pattern
stratafix PDS plus antibacterial suture
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device
Stratafix being held by a tool with a needle
Stratafix strand laid out in a swirl pattern
stratafix PDS plus antibacterial suture
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

About this device

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is a next generation antibacterial, absorbable, barbed suture solution. With unidirectional anchors, a surgical needle on one end, and a fixation tab on the other, STRATAFIX™ enables tissue approximation without surgical knots.14

Specialties

For use in, but not limited to: Orthopaedics, Cardiovascular, OB/GYN, General, Hernia, Hepatobiliary, Neurosurgery, Colorectal, Bariatrics, Plastics, Urology and Vascular

Procedures

For use in open, laparoscopic and robotic procedures, including but not limited to: Abdominoplasty, Breast Reconstruction, C-section, CABG, Myomectomy, Hysterectomy, Laparotomy, Midline Closure, Total Knee Replacement, Total Hip Replacement, Spinal Procedures, Hernia Repair, Sleeve Gastrectomy, Gastric Bypass, Prostatectomy, Nephrectomy, Left, Right, or Sigmoid Colectomy, Low Anterior Resection, Sternotomy, Thoracotomy, and Hepatectomy

Economic benefits

In a total joint arthroplasty, watertight multi-layer closure comparing conventional sutures and staples with STRATAFIX™ Symmetric Plus Knotless Tissue Control Device, STRATAFIX™ Spiral Knotless Tissue Control Device and DERMABOND™ PRINEO™ Skin Closure System was associated with15:

  • Significantly lower incidence of discharge to a non-home settingC
  • Significantly increased days to readmissionD
  • Significantly shorter length of stayD
  • Significantly fewer reoperations within 90 daysD

Clinical outcomes

In a randomized controlled ex-vivo human cadaveric study with arthrotomies closed using STRATAFIX™ Symmetric on one knee and interrupted conventional suture on the contralateral knee from the same donor, STRATAFIX™ was associated with16:

  • Lower leak rate, indicating that there was no “sawing effect” of the barbs on the tissue
  • Better watertight closure in dynamic motion and suture release scenarios
  • Better maintenance of the knee arthrotomy closure

Clinical evidence

STRATAFIX™ is the only antibacterial barbed suture available worldwide.13B

28%

reduction in SSI risk

Demonstrated in a meta-analysis using traditional triclosan-coated sutures.17EFG

99.9%

fewer bacteria

STRATAFIX™ exhibited 99.9% fewer bacteria than non-triclosan-coated QUILL™ MONODERM™ and V-Loc™ 90 sutures in an in vitro test.18,19H

14,000+

patients impacted

ETHICON™ Plus Antibacterial Sutures were studied in 31 RCTs with over 14,000 patients.20,21I

Features & benefits

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

Strength

STRATAFIX™ Symmetric PDS™ Plus Devices demonstrated superior tissue holding strength compared to interrupted technique with Coated VICRYL™ (polyglactin 910) Suture, continuous technique with PDS™ Plus Antibacterial (polydioxanone) Suture, and V-Loc™ 180 Wound Closure Device.1JK

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

Efficiency

STRATAFIX™ Barbed Sutures can close wounds substantially faster than using an interrupted technique,22-24 which may result in significant time savings in the OR.

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

Protection

The antibacterial coating of the STRATAFIX™ Symmetric PDS™ Plus Device prevents bacteria colonization of the suture in vitro25L

STRATAFIX™ Knotless Tissue Control Devices with Plus Antibacterial Technology are proven to kill bacteria on the suture linked to SSIs in vivo and inhibit bacteria for 11 days or more in vitro.13*M


*Triclosan has in vitro activity that inhibits bacterial colonization of the suture. Petri dish image for illustrative purposes only.

Learn how to use this device

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

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Supporting documentation

PDF

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device multiple strand technique guide

PDF

STRATAFIX™ Knotless Tissue Control Device portfolio brochure

PDF

STRATAFIX™ Knotless Tissue Control Device portfolio robotic surgery brochure

PDF

STRATAFIX™ Knotlles Tissue Control Device product catalog

PDF

Anatomy of a barbed suture brochure
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Related education

Related products

STRATAFIX™ Spiral Knotless Tissue Control Devices

STRATAFIX™ Spiral Knotless Tissue Control Devices

STRATAFIX™ is a portfolio of barbed suture products that offers a variety of barbed structure, polymers, and undirectional and bidirectional designs to accommodate a wide variety of procedures. View device specifications for full portfolio offering.


STRATAFIX™ Spiral Knotless Tissue Control Devices represent the next generation of suturing devices, eliminating the need for knot tying while suturing.1,2 Fixating barbs allows you to maintain tension on each pass for more security, consistency, and efficiency than traditional sutures.3-11 Smooth tissue passage and a secure hold help you control tension and achieve excellent tissue approximation.1,3-8,12 Unlike non-triclosan-coated QUILL™ MONODERM™ and V-Loc™ 90 sutures, STRATAFIX™ has antibacterial protection—shown to inhibit bacterial colonization of the suture in an in vitro test.13,14A

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References

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

B. Refers only to STRATAFIX™ Symmetric PDS™ Plus, STRATAFIX™ Spiral PDS™ Plus and STRATAFIX™ Spiral Monocryl™ Plus.

C. Total Joint Arthroplasty data extracted from Electronic Medical Records at Valley Medical Center (VMC), based on unadjusted outcomes, University of Washington (p=0.0031), n=2107, 01/2014 – 03/2019

D. Total Joint Arthroplasty data extracted from Electronic Medical Records at Valley Medical Center (VMC), based on unadjusted outcomes, University of Washington, (p<0.0001), n=2107, 01/2014 – 03/2019

E. In a meta-analysis of 21 RCTs, 6462 patients, 95% CI: (14, 40%), P<0.001

F. All triclosan-coated sutures in these RCTs were Ethicon Plus Antibacterial Sutures (MONOCRYL™ Plus, VICRYL™ Plus, and PDS™ Plus)

G. All triclosan-coated sutures in these RCTs were Ethicon Plus Antibacterial Sutures (MONOCRYL™ Plus Antibacterial poliglecaprone 25 Suture, Coated VICRYL™ Plus Antibacterial polyglactin 910 Suture, and PDS™ Plus Antibacterial polydioxanone Suture). STRATAFIX™ are the only barbed sutures with Plus Antibacterial Technology

H. In vitro studies comparing STRATAFIX™ Spiral MONOCRYL™ Plus vs. QULL™ MONODERM™ and STRATAFIX™ Spiral MONOCRYL™ Plus vs. V-Loc™ 90 using 24-hour incubation with high concentrations of S. aureus.

I. Source: National Institute for Health and Care Excellence. Plus Sutures for preventing surgical site infection. Medical technologies guidance [MTG59]. June 28, 2021.

J. In an ex vivo model.

K. Superior to VICRYL and PDS™ Plus Antibacterial (polydioxanone) Suture in fascia. Superior to V-Loc in subcutaneous tissue.

L. As shown with SEM imagery.

M. Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-resistant S. aureus (MRSA), Methicillin-resistant S. epidermidis (MRSE), Escherichia coli, Klebsiella pneumoniae.

  1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015. Ethicon, Inc.
  2. V-Loc 180 Absorbable Wound Closure Device. Instructions for Use. Medtronic.
  3. 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.
  4. Warner JP, Gutowski KA. Abdominoplasty with progressive tension closure using a barbed suture technique. Aesthet Surg J. 2009;29(3):221-225.
  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. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopaedics. 2011;34(9):e473-e475. doi: 10.3928_01477447-20110714-35.
  9. Ethicon, Inc. 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.
  10. Ethicon, Inc. Performance Testing of STRATAFIX SYMMETRIC PDS PLUS Size 0 & 1 Devices – Initiation Strength in Porcine Tissue. AST-2013-0603.
  11. Ethicon, Inc. 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.
  12. Ethicon, Inc. AST-2013-0056 Performance Testing of STRATAFIX Symmetric PDSSize2-0 suture device for Tissue Holding Strength with Multiple Incision Defects to Measure Gapping.
  13. Bhende S, Burkley D, Nawrocki J. In vivo and in vitro anti-bacterial efficacy of absorbable barbed polydioxanone monofilament tissue control device with triclosan. Surg Infect (Larchmt). 2018;19(4):430-437.
  14. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Instructions for Use. Ethicon, Inc.
  15. Flener, JL., Chen, BP., Ernst FR., Libolt, A. & Barrett, WP. (2022) Advanced Multi-Layer, Watertight Closure in Total Joint Replacement: A Retrospective Study. Value in Health, Volume 25, Issue 12S, CO75 (December 2022).
  16. Fillingham YA, Matonick JP, Mendoza V, Parvizi J. Comparing the watertight closure of barbed and conventional suture under static and dynamic conditions in an ex‐vivo human knee arthrotomy model. Arthroplast Today. 2021;12:1‐6.
  17. 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. Brit J Surg. 2017;ePub-DOI: 10.1002_bjs.10445.
  18. Bhende S. Comparative evaluation of bacterial colonization on STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device vs QUILL MONODERM™ Wound Closure Device using attachment assay and scanning electron microscopy. AST-2020-0090. August 17, 2020. Ethicon, Inc.
  19. 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.
  20. Plus Sutures for preventing surgical site infection. National Institute for Health and Care Excellence. June 28, 2021. Accessed January 31, 2023. https:__www.nice.org.uk_guidance_mtg59_resources_plus-sutures-for-preventing-surgical-site-infection-pdf-64372124642245
  21. Supporting documentation – Committee papers. National Institute for Health and Care Excellence. April 2021. Accessed January 31, 2023. https:__www.nice.org.uk_guidance_mtg59_documents_supporting-documentation
  22. Greenberg J, Goldman R. Barbed Suture: A Review of the Technology and Clinical Uses in Obstetrics and Gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-115.
  23. Sundaram, K., Piuzzi, N. S., Klika, A. K., Molloy, R. M., Higuera-Rueda, C. A., Krebs, V. E., &amp; Mont, M. A. (2020). Barbed sutures reduce arthrotomy closure duration and suture utilisation compared to interrupted conventional sutures for primary total hip arthroplasty: A randomised controlled trial. HIP International, 31(5), 582–588.
  24. Sundaram, K., Warren, J. A., Klika, A., Piuzzi, N. S., Mont, M. A., &amp; Krebs, V. (2020). Barbed sutures reduce arthrotomy closure duration compared to interrupted conventional sutures for total knee arthroplasty: A randomized controlled trial. MUSCULOSKELETAL SURGERY, 105(3), 275–281. https:__doi.org_10.1007_s12306-020-00654-y.
  25. 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.


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


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