STRATAFIX - J&J Medical Devices · V-LOC portfolio does not offer antibacterial products. 7,8. Quill™ portfolio does not offer antibacterial products. 3–6. Exceptional Tensile

Bidirectional

STRATAFIX™ The Most Comprehensive Portfolio of Knotless Tissue Control Devices

Stratafix™

FeaturesSTRATAFIX™ Knotless Tissue Control Devices

V-LOC™

Wound Closure Devices

Quill™ Knotless Tissue Closure Devices

Superior tissue holding strength** ü 1, *No 2 No 3-6

Antibacterial properties ü 1, †No 2 No 3-6

Exceptional tensile wound holding strength ü 1, *No 7,8 ü 4

Appropriate for use in fascia ü 1, 9,*No 7,8 No 3-6

Excellent needle performance ü 10No 10 No 10

Multiple anchor designs ü 1No 11 No 12

** compared to interrupted technique with Coated VICRYL™ (polyglactin 910) Suture, continuous technique with PDS® II (polydioxanone) Suture, and V-Loc™ 180 Wound Closure Device.

* Specific to STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device.

† Does not apply to all products in portfolio. Specific to STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device, STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, and STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device.

STRATAFIX™ Symmetric Knotless Tissue Control Device

Unidirectional

STRATAFIX™ Spiral Knotless Tissue Control Devices

Unidirectional

STRATAFIX™ Symmetric PDS Plus Device

™ 180 Absorbable Wound Closure Device

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Tissue Holding Strength13

78.38

90.05

Size 2-0, Subcutaneous

Size 2-0, Subcutaneous

Antibacterial Properties1,7

V-LOC™

STRATAFIX™ Spiral Plus Device

The Zone of inhibition image is shown for illustrative purposes only and may not be an exact representation of the zone of inhibition. The area of media where bacteria are unable to visibly grow due to the presence of IRGACARE®† MP (Triclosan) in Plus Antibacterial Sutures during zone of inhibition testing varies. A trademark of BASF SE.

The third-party trademarks used herein are trademarks of their respective owners. * Refers to STRATAFIX™ Symmetric PDS™ Plus Device only.

References: 1. Data on file, Ethicon, Inc. STRATAFIX™ Knotless Tissue Control Devices Consolidated Claims Matrix 060056-160915 EMEA 2. V-LOC Wound Closure Devices Product Overview. Covidien AG. 2011. 3. Quill Self-Retaining System (SRS) Comprised of Monoderm (PGA_PCL) Synthetic Absorbable Surgical Suture Material [Instructions for Use]. Reading, PA: Angiotech Pharmaceuticals, Inc; 2007. 4. Quill Self-Retaining System (SRS) Comprised of Dyed PDO (Polydioxanone) Synthetic Absorbable Surgical Suture Material [Instructions for Use]. Reading, PA: Angiotech Pharmaceuticals, Inc; 2007. 5. Quill Self-Retaining System (SRS) Comprised of Polypropylene Non-absorbable Surgical Suture Material [Instructions for Use]. Reading, PA: Angiotech Pharmaceuticals, Inc; 2009. 6. Quill Self-Retaining System (SRS) Comprised of Nylon Non-absorbable Surgical Suture Material [Instructions for Use]. Reading, PA: Angiotech Pharmaceuticals, Inc; 2008. 7. V-LOC 180 Absorbable Wound Closure Device [Instructions for Use]. Norwalk, CT: Covidien AG; 2010. 8. V-LOC 90 Absorbable Wound Closure Device [Instructions for Use]. Norwalk, CT: Covidien AG; 2010. 9. Ethicon, AST-2013-0603. Performance Testing of STRATAFIX™ SYMMETRIC PDS PLUS Size 0 & 1 Devices – Initiation Strength in Porcine Tissue. Data on File. April 2014. 10. Ethicon, CT12-009, CTX, CT-1, MH, FS, FS-2 Competitive Assessment (AC), Data on File, Dec 2012 1 1. V-LOC Wound Closure Devices For Use in General Surgery. Covidien AG. 2011. 12. Quill Knotless Tissue Control Device General Product Information. http://www.quilldevice.com/general-product-information. Angiotech Pharmaceuticals, Inc. 2013. Accessed 14 Nov, 2016. 13. Ethicon, 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. Data on File. May 2015.

Features STRATAFIX™ Knotless Tissue Control Devices V-LOC™ Wound Closure Devices Quill™ Knotless Tissue Closure Devices

Superior tissue holding strength

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device demonstrated superior tissue holding strength in fascia when compared to PDS™ Loop continuous technique and VICRYL™ interrupted technique 13

Inferior tissue holding strength when compared to STRATAFIX™ Symmetric PDS™ Plus Devices in subcutaneous tissue 13

Inferior tissue holding strength compared to STRATAFIX™ Symmetric PDS Plus Device in subcutaneous tissue 13

Antibacterial properties

STRATAFIX™ Symmetric PDS Plus Device, STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device and STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device 1

V-LOC portfolio does not offer antibacterial products7,8

Quill™ portfolio does not offer antibacterial products 3–6

Exceptional Tensile Strength

STRATAFIX™ Spiral PDO Knotless Tissue Control Device, STRATAFIX™ Spiral PDS Plus Device, and STRATAFIX™ Symmetric PDS Plus Device can be used in closures that require up to 6 weeks of tissue approximation1

The V-LOC™ 180 Absorbable Wound Cosure Device is not for use where prolonged (beyond 3 weeks) approximation of tissues under stress is required 7

Quill™ PDO can be used in closures that require up to 6 weeks of tissue approximation4

Appropriate for use in fascia

STRATAFIX™ Symmetric PDS Plus Device is designed for use in high-tension areas, such as fascia1

Warning in label states the safety and effectiveness of V-LOC has not been established for use in fascial closures7, 8

Warning in label states the safety and effectiveness of Quill™ has not been established for use in fascial closures 3–6

Superior needle performance

Ethicon needles outperform competition due to10:• excellent strength and ductility • improved penetration • reduced tissue trauma• advanced silicone coating

Covidien needles require more penetration force versus Ethicon reverse-cutting and taper-point needles10

Angiotech needles require more penetration force versus Ethicon reverse-cutting and taper-point needles10

Multiple anchor designs

• Available in spiral designs (bidirectional and unidirectional) and symmetric designs

• Available in “cut” and “punched” technologies1

• Available in spiral design only 11

• Only available in “cut” technologies• Available in spiral design only 12

• Only available in “cut” technologies

A full portfolio of knotless tissue control devices to ameet Surgeons’ needs for a broad range of surgical applications.

Only Ethicon offers tissue control devices, with Plus antibacterial technology, that provide appropriate strength for closing high-tension areas, such as fascia 1, *

Please always refer to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

www.ethicon.com

© Ethicon Endo-Surgery (Europe) GmbH 2016, 056468-160714 EMEA