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Medtronic / Covidien Products / Hernia Repair / Versatex™ Monofilament Mesh

Overview

Designed to Offer Excellent Hernia Repair Performance.([FOOTNOTE=Based on Versatex™ Monofilament Mesh IFU # PT00001732.],[ANCHOR=],[LINK=]),([FOOTNOTE=D. Weyhe, W. Cobb, D. Lomanto et al, Comparative analysis of the performance of a series of meshes based on weight and pore size in a novel mini-pig hernia model - EHS 2013.],[ANCHOR=],[LINK=]),([FOOTNOTE=Based on Covidien internal test report # T2306CR062a/TEX044d evaluating 3DS/3DV textile characterization. April 2015.],[ANCHOR=],[LINK=])

Versatex™ monofilament mesh is composed of polyester material and large pore size, which are the main determinants of local tissue tolerance (successful mesh integration and favorable tissue response).†,2,3,([FOOTNOTE=Based on Covidien internal test report # T2306CR022a assessing safety and local tolerance. October 2014.],[ANCHOR=],[LINK=])

Versatex™ mesh is designed to simplify intra-operative handling for surgeons through improved visualization, ease of mesh positioning, and wide selection of mesh sizes.([FOOTNOTE=Based on Covidien internal test report # T2306CR044a evaluating design for improved visualization during placement. March 2015.],[ANCHOR=],[LINK=]),([FOOTNOTE=Based on Covidien internal report # T2306CR043a assessing size and shape comparison chart. March 2015.],[ANCHOR=],[LINK=]),([FOOTNOTE=Based on Versatex™ monofilament mesh evaluation by surgeons for design validation. Covidien internal report # T2306CR053b. March 2015.],[ANCHOR=],[LINK=])

Features

Smart Design.

Innovative Features for Streamlined Performance in Preperitioneal Hernia Repair.

  • Hydrophilic, monofilament textile3,([FOOTNOTE=O. Lefranc, Y. Bayon, S. Montanari, P. Gravagna, M. Therin, Reinforcement Material in Soft Tissue Repair: Key Parameters Controlling Tolerance and Performance - Current and Future Trends in Mesh Development. P. von Theobald et al. (eds.), New technics in general Prolaps surgery 2011 p. 275-287.],[ANCHOR=],[LINK=])
  • Base textile with exclusive 3D construct3
  • Macroporous (2.1 x 3.0 mm) with hexagonal shape3,([FOOTNOTE=Based on Covidien internal test report # T2306CR042b assessing physical and mechanical properties of Versatex™ vs. current meshes on the market. April 2015.],[ANCHOR=],[LINK=]),([FOOTNOTE=C. Deeken, M. Abdo, M. Frisella, B. Matthews, Physicomechanical Evaluation of Polypropylene, Polyester, and Polytetrafluoroethylene Meshes for Inguinal Hernia Repair. Published J Am Coll Surg 2011.],[ANCHOR=],[LINK=])
  • Medium weight (64 g/m2)3,10
  • Robust mechanical strength with balanced softness and rigidity1-3,7
  • Comprehensive range for open ventral and open/lap inguinal defects6,7
  • Flexible stocking options available in single and 3-unit packaging6

Smart Handling.

Experience Ease of Use in Preperitoneal Hernia Repair.

  • Mesh transparency for improved anatomy visualization during placement and fixation5
  • Centering and orientation marking facilitates mesh positioning.7
  • Flexibility for easy mesh handling and abdominal wall conformability.7

Smart Repair.

Designed to Offer Excellent Hernia Repair Performance1-3

  • 3D macroporous structure with hexagonal pore shape delivers reinforced textile strength and facilitates excellent tissue ingrowth2,3
  • Balanced combination of macroporosity, surface density and mechanical strength for successful hernia repair1,3,10,([FOOTNOTE=Lake S, Zihny A, Deekan C. et al: Pore size and pore shape – but not mesh density – alter the mechanical strength of tissue ingrowth into synthetic mesh materials in a porcine model of ventral hernia repair.],[ANCHOR=],[LINK=])
  • Designed for improved mesh integration and reduced complications related to mesh shrinkage and scar plate formation2,3
Order Information
Order Code Description Unit of Measure Quantity
VTX1106 Versatex™ Monofilament Mesh/11*6 cm Box 1
VTX1106X3 Versatex™ Monofilament Mesh/11*6 cm Box 3
VTX1510 Versatex™ Monofilament Mesh/15*10 cm Box 1
VTX1510X3 Versatex™ Monofilament Mesh/15*10 cm Box 3
VTX1515 Versatex™ Monofilament Mesh/15*15 cm Box 1
VTX1515X3 Versatex™ Monofilament Mesh/15*15 cm Box 3
VTX1515M Versatex™ Monofilament Mesh/15*15 cm Box 1
VTX1515MX3 Versatex™ Monofilament Mesh/15*15 cm Box 3
VTX2020M Versatex™ Monofilament Mesh/20*20 cm Box 1
VTX3030M Versatex™ Monofilament Mesh/30*30 cm Box 1
VTX4530M Versatex™ Monofilament Mesh/45*30 cm Box 1
VTX5050M Versatex™ Monofilament Mesh/50*50 cm Box 1
Specifications
Device Classification Versatex™ monofilament mesh is intended for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
Material Composition 3D textile non-absorbable monofilament polyester (PET) – base textile
2D textile non-absorbable monofilament polyester (PET) – green marking textile
Pore Size3 2.1 mm x 3.0 mm
Pore Shape3 Hexagon
Weight3 Surface density (64g/m2)
Sterilization Method Gamma Radiation
Shelf Life 5 Years
Fixation Device Compatibility Compatible with current fixation devices on the market including Reliatack™ articulating reloadable fixation device7,13,14,15
Ability to be Re-cut Can be trimmed to size without fraying16
Trocar Compatibility Can be introduced through a 10mm trocar without being damaged7,17

Order Information

  • 13. Based on Covidien internal report # T2306CR040a evaluating compatibility of Versatex™ Monofilament Mesh with AbsorbaTack™ 30X. February 2015.

  • 14. Based on Covidien internal report # T2306CR050a assessing compatibility of Type 3DS/3DV textile with different fixation means. February 2015.

  • 15. Based on Covidien internal test report # T2306CR060a evaluating compatibility of Versatex™ Monofilament Mesh with ReliaTack™ Articulating Reloadable Fixation Device. February 2015.

  • 16. Based on Covidien internal report # T2306CR046a assessing ability of Versatex™ monofilament mesh to be trimmed to size without fraying. March 2015.

  • 17. Based on Covidien internal report # T2306CR010b assessing ability of Versatex™ monofilament mesh to be introduced through a trocar. March 2015.

  • † As demonstrated in porcine hernia model.

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