Intended for healthcare professionals

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

Contact repDevice specifications
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral Knotless Tissue Control Devices

About this device

STRATAFIX™ Spiral Knotless Tissue Control Devices employ barbs in a spiral pattern, enabling tissue approximation without tying surgical knots.15-18 STRATIFIX™ Spiral Knotless Tissue Control Devices offer a range of solutions.

Absorbable designs come in both bidirectional and unidirectional configurations, with antibacterial protection and the choice of dyed or undyed PDS™ and MONOCRYL™ polymers.15-18 


Non-absorbable designs are offered in both bidirectional and unidirectional options with polypropylene polymer.19-20

Specialties

For use in, but not limited to: Orthopaedics, Cardiovascular, OB/GYN, General, Hernia, Hepatobiliary, Neurosurgery, Colorectal, Hernia, 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, Hepatectomy

Economic benefits

Using STRATAFIX™ Knotless Tissue Control Devices in spinal fusion and laminectomy procedures were associated with significantly lower OR time and costs when compared to traditional sutures21B:

  • Significant reduction in OR time by 24 minutes 
  • $427 lower average OR cost

Clinical outcomes

In a randomized clinical trial comparing STRATAFIX™ Spiral Knotless Tissue Control Device bidirectional to traditional suturing during uterine closure in C-section, STRATAFIX™ was associated with22CD:

  • 18% reduced blood loss (P<0.005)
  • 49% fewer hemostatic sutures required (P<0.001)
  • 36% faster uterine closure (P<0.001)
Clinical outcomes

Clinical evidence

STRATAFIX™ is the only antibacterial barbed suture available worldwide23E

28%

reduction in SSI risk

Demonstrated in a meta-analysis using traditional triclosan-coated sutures24FG

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 test13,14H

14,000+

patients impacted

ETHICON™ Plus Antibacterial Sutures were studied in 31 RCTs with over 14,000 patients.25,26I

Features & benefits

stratafix spiral

Strength

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices provides 6 week soft tissue support, while Medtronic’s V-Loc™ 180 Device provides support for only 3 weeks.27,28

stratafix spiral

Efficiency

STRATAFIX™ barbed sutures can close wounds substantially faster than using an interrupted technique,29-31 which can result in significant time savings in the OR. Bidirectional STRATAFIX™ Spiral Knotless Tissue Control Devices improved efficiency by allowing 2 health care professionals to close at the same time with a single device.

stratafix spiral

Protection

STRATAFIX™ address a known risk factor for surgical site infection (SSI) — bacterial colonization of the suture32,33

  • Proven in vivo to kill bacteria on the suture known to be associated with SSI23
  • Have been shown in vitro to inhibit colonization of the suture for 11 days or more23


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™ Spiral Knotless Tissue Control Devices

Supporting documentation

PDF

STRATAFIX™ Spiral Unidirectional MONOCRYL™ Plus (Dyed) Knotless Tissue Control Device brochure

PDF

STRATAFIX™ Knotless Tissue Control Device portfolio brochure

PDF

STRATAFIX™ Knotless Tissue Control Device portfolio robotic surgery brochure

PDF

STRATAFIX™ Knotless Tissue Control Device product catalog

PDF

Anatomy of a barbed suture brochure
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Related education

Related products

Stratafix being held by a tool with a needle

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

View full product details

References

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

B. 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) than traditional sutures.

C. RCT; N=102.

D. Coated VICRYL™ (polyglactin 910) Suture.

E. Refers only to STRATAFIX™ Symmetric PDS™ Plus, STRATAFIX™ Spiral PDS™ Plus and STRATAFIX™ Spiral MONOCRYL™ Plus.

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

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

H. In vitro studies comparing STRATAFIX™ Spiral MONOCRYL™ Plus vs. QUILL™ 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.

  1. 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.
  2. Warner JP, Gutowski KA. Abdominoplasty with progressive tension closure using a barbed suture technique. Aesthet Surg J. 2009;29(3):221-225.
  3. 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.
  4. 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.
  5. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.
  6. 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.
  7. Ethicon, Inc.: 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015.
  8. 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.
  9. Ethicon, Inc. Performance Testing of STRATAFIX SYMMETRIC PDS PLUS Size 0 & 1 Devices – Initiation Strength in Porcine Tissue. AST-2013-0603.
  10. 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.
  11. 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.
  12. Nawrocki J. Technical memo: Explanation on the science behind the anchors on knotless tissue control devices. 2017. Ethicon, Inc.
  13. 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.
  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. STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device Instructions for Use. Ethicon, Inc.
  16. STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device Instructions for Use. Ethicon, Inc.
  17. STRATAFIX™ Spiral PDS™ Plus Unidirectional Knotless Tissue Control Device Instructions for Use. Ethicon, Inc.
  18. STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device Instructions for Use. Ethicon, Inc.
  19. STRATAFIX™ Spiral Polypropylene Unidirectional Knotless Tissue Control Device Instructions for Use. Ethicon, Inc.
  20. STRATAFIX™ Spiral Polypropylene Bidirectional Knotless Tissue Control Device Instructions for Use. Ethicon, Inc.
  21. 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.
  22. Peleg D, Ahmad RS, Warsof SL, et al. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at cesarean delivery. Am J Obstet Gynecol. 2018;218(3):343.e1-343.e7.
  23. 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.
  24. 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.
  25. 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
  26. 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
  27. Report for Assessment of Real Time In-Vitro BSR Testing of STRATAFIX Spiral PDS PLUS, STRATAFIX Spiral Monocryl PLUS, V-Loc 90 and V-Loc 180 barbed suture devices.
  28. V-Loc™ Wound Closure Device Instructions for Use. Medtronic.
  29. 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.
  30. 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.
  31. 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
  32. 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.
  33. 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.



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

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