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 The barbs are uniquely designed and provide maximum holding in soft tissue where PDS™ Plus Suture is commonly used, including in high tension areas such as abdominal wall fascia, knee extensor mechanism fascia during a total knee replacement, deep hip fascia used during a total hip replacement, deep lumbar fascia during spine surgery, closure of mini-laparotomy incisions in patients with BMI less than 30 kg/m², and ventral hernia fascial closure with mesh.3 It is a next generation suture device that eliminates the need for knot-tying or need for an assistant to follow the suture.4,5 In addition, STRATAFIX™ Devices are the only antibacterial barbed suture available worldwide.6B
.png?width=3840&quality=90&format=webp)
.png?width=3840&quality=90&format=webp)
.png?width=3840&quality=90&format=webp)
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.7
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 with8:
- 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
Closure performance 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 with9:
- 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.6B
28%
reduction in SSI risk
Demonstrated in a meta-analysis using traditional triclosan-coated sutures.10EFG
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.11,12H
14,000+
patients impacted
ETHICON™ Plus Antibacterial Sutures were studied in 31 RCTs with over 14,000 patients.13,14I
Features & benefits
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
Efficiency
STRATAFIX™ Barbed Sutures can close wounds substantially faster than using an interrupted technique,15-17 which may result in significant time savings in the OR.
.png?width=3840&quality=90&format=webp)
Protection
The antibacterial coating of the STRATAFIX™ Symmetric PDS™ Plus Device prevents bacteria colonization of the suture in vitro18L
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.6*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
Supporting documentation
Related products
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 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
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 Monocry|™ 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.
- 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015. Ethicon, Inc.
- V-Loc 180 Absorbable Wound Closure Device. Instructions for Use. Medtronic.
- U.S. Food & Drug Administration. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices Approval Letter. May 18, 2026.
- 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.
- Warner JP, Gutowski KA. Abdominoplasty with progressive tension closure using a barbed suture technique. Aesthet Surg J. 2009;29(3):221-225.
- 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.
- STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Instructions for Use. Ethicon, Inc.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- Sundaram, K., Piuzzi, N. S., Klika, A. K., Molloy, R. M., Higuera-Rueda, C. A., Krebs, V. E., & 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.
- Sundaram, K., Warren, J. A., Klika, A., Piuzzi, N. S., Mont, M. A., & 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.
- 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.
Safety and effectiveness has not been established in closure of full (>10 cm) laparotomy incisions, or in patients with BMI >30 kg/m2 and use in these scenarios could result in wound dehiscence or incisional hernia. This should not supersede good clinical judgement.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
The third-party trademarks used herein are trademarks of their respective owners.
US_SRG_WOUN_126195.2