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STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX Spiral Devices provide more efficiency, security, and consistency than traditional sutures.1-3 Available with Plus Antibacterial Technology to address a known risk factor for surgical site infection (SSI).4,5
Features and Benefits
STRATAFIX™ barbed sutures can close wounds substantially faster than using an interrupted technique,6 resulting in significant time savings in the OR.6 Bidirectional STRATAFIX Spiral Devices improve efficiency by allowing 2 clinicians to close at the same time with a single device.
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are as strong as V-Loc™ 180 Wound Closure Devices at time zero and provide greater strength retention over time.7-9*†
STRATAFIX™ are the only commercially available barbed sutures with triclosan, which inhibits methicillin-resistant S aureus (MRSA), methicillin-resistant S epidermidis (MRSE), and other bacteria linked to SSIs.10‡§|| Head-to-head studies showed STRATAFIX™ Devices had 99% less surface bacteria than V-Loc™ Devices.11,12
Smooth passage and secure hold
The barbs on STRATAFIX Spiral Devices are uniquely designed to retract into the core for smooth tissue pull through and then reengage for a secure, 3-dimensional hold.1,2,13-19
*In an ex vivo porcine model.
†As demonstrated by 6-week in vitro testing.
‡PDS® Plus and MONOCRYL® Plus sutures only.
§Staphylococcus aureus, Staphylococcus epidermidis, methicillin-resistant S aureus (MRSA), methicillin-resistant S epidermidis (MRSE), Escherichia coli, and Klebsiella pneumoniae.
||Refers only to STRATAFIX™ Symmetric PDS™ Plus, STRATAFIX™ Spiral PDS™ Plus, and STRATAFIX™ Spiral Monocryl™ Plus.
1. 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.
2. Vakil JJ, O'Reilly MP, Sutter EG, Mears SC, Belko SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713.
3. Nonnenman H. 100326296: Time zero tissue holding - Competitive claims comparisons for STRATAFIX Knotless Tissue Control Devices vs various products. 2015. Ethicon, Inc.
4. 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.
5. 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):201-208.
6. 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.
7. Nonnenmann H. Performance Testing Report for STRATAFIX Spiral PDS Plus – Mechanical Testing. 100491281-Rev 1. November 17, 2016. Ethicon, Inc.
8. Nawrocki J. Report for Assessment of Benchtop Tissue Holding Strength of STRATFIX Spiral PDS PLUS, STRATAFIX Spiral Monocryl PLUS, V-Loc 90 and V-Loc 180 barbed suture devices. 100559286. July 19, 2017. Ethicon, Inc.
9. Nawrocki J. 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. 100552029. July 14, 2017. Ethicon, Inc.
10. 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.
11. 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.
12. 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.
13. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.
14. 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.
15. 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.
16. Nawrocki J. Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 100326296. May 20, 2015. Ethicon, Inc.
17. Overaker D. ETH ICON Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitching patterns. AST-2012-0331. August 24, 2012. Ethicon, Inc.
18. Nawrocki J. Technical Memo - Explanation on the Science behind the Anchors on Knotless Tissue Control Devices. Ethicon, Inc.
19. Ethicon Stratafix Unidirectional CAD File. 2013. Ethicon, Inc.
© Ethicon US, LLC. 2019. 085133-171129
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