much more than a mesh - medtronic

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MUCH MORE THAN A MESH Providing the Flexibility of Choice

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Page 1: MUCH MORE THAN A MESH - Medtronic

MUCH MORE THAN A MESH

Providing the Flexibility of Choice

Page 2: MUCH MORE THAN A MESH - Medtronic

OUR MESHES BENEFIT FROM THESE ESSENTIAL QUALITIES:

POROSITY

COMPLIANCE

Limited scarringOptimized textile composition incorporating superior macro-porous structure and pore-shape to facilitate excellent tissue ingrowth.1-13

Patient comfortCombined mechanical properties of elasticity and strength designed to deliver the best possible abdominal wall conformability.10, 14, 15, 16, 17

Page 3: MUCH MORE THAN A MESH - Medtronic

COMPATIBLE

DURABILITY

THE RIGHT MESHFOR THE RIGHT PATIENTOVER 20 YEARS CLINICAL SUCCESS

Quick integrationThe surface properties of balanced mesh technology aid early tolerance and rapid acceptance during the critical phase of wound healing for a successful hernia repair.1, 5, 6, 8, 9

Consistent, proven and strongCompelling long-term clinical results with an uncompromised track record of quality in development and manufacturing in Europe.

Page 4: MUCH MORE THAN A MESH - Medtronic

Ordering InformationINGUINALOrder Code Description Dimensions Qty

PPM1106 Parietene™ Macroporous Mesh 11 x 6 cm box of 1

PPM1106X3 Parietene™ Macroporous Mesh 11 x 6 cm box of 3

PPM1106X6 Parietene™ Macroporous Mesh 11 x 6 cm box of 6

PPM1508 Parietene™ Macroporous Mesh 15 x 7.5 cm box of 1

PPM1508X3 Parietene™ Macroporous Mesh 15 x 7.5 cm box of 3

PPM1508X6 Parietene™ Macroporous Mesh 15 x 7.5 cm box of 6

PPM1510 Parietene™ Macroporous Mesh 15 x 10 cm box of 1

PPM1510X3 Parietene™ Macroporous Mesh 15 x 10 cm box of 3

PPM1510X6 Parietene™ Macroporous Mesh 15 x 10 cm box of 6

PPM1515 Parietene™ Macroporous Mesh 15 x 15 cm box of 1

PPM1515X3 Parietene™ Macroporous Mesh 15 x 15 cm box of 3

PPM1515X6 Parietene™ Macroporous Mesh 15 x 15 cm box of 6

PPMK1106 Parietene™ Macroporous Keyhole Mesh 11 x 6 cm box of 1

PPMK1106X3 Parietene™ Macroporous Keyhole Mesh 11 x 6 cm box of 3

PPMK1106X6 Parietene™ Macroporous Keyhole Mesh 11 x 6 cm box of 6

PPMK1508 Parietene™ Macroporous Keyhole Mesh 15 x 7.5 cm box of 1

PPMK1508X3 Parietene™ Macroporous Keyhole Mesh 15 x 7.5 cm box of 3

PPMK1508X6 Parietene™ Macroporous Keyhole Mesh 15 x 7.5 cm box of 6

VENTRALOrder Code Description Dimensions Qty

PPM2020 Parietene™ Macroporous Mesh 20 x 20 cm box of 1

PPM2020X3 Parietene™ Macroporous Mesh 20 x 20 cm box of 3

PPM3030 Parietene™ Macroporous Mesh 30 x 30 cm box of 1

PPM3030X3 Parietene™ Macroporous Mesh 30 x 30 cm box of 3

PPM4530 Parietene™ Macroporous Mesh 45 x 30 cm box of 1

PPM4530X3 Parietene™ Macroporous Mesh 45 x 30 cm box of 3

The balanced polypropylene choice18-22

■ Monofilament Polypropylene (PPL)

■ Hexagonal pore shape

■ Optimal surface density (46 g/m2)

■ Pore size of 2.0 mm x 2.4 mm

■ Trimming to size without fraying

PARIETENE™ MACROPOROUS MESH

Page 5: MUCH MORE THAN A MESH - Medtronic

The smart 3-D choice1

■ Monofilament Polyester (PET)

■ Hexagonal pore shape

■ Medium-weight surface density (64 g/m2)

■ Pore size of 2.1 mm x 3.0 mm

■ Marking to facilitate positioning

Ordering InformationINGUINALOrder Code Description Dimensions Qty

VTX1106 Versatex™ Monofilament Mesh Rectangular 11 x 6 cm box of 1

VTX1106X3 Versatex™ Monofilament Mesh Rectangular 11 x 6 cm box of 3

VTX1510 Versatex™ Monofilament Mesh Rectangular 15 x 10 cm box of 1

VTX1510X3 Versatex™ Monofilament Mesh Rectangular 15 x 10 cm box of 3

VTX1515 Versatex™ Monofilament Mesh Square 15 x 15 cm box of 1

VTX1515X3 Versatex™ Monofilament Mesh Square 15 x 15 cm box of 3

VENTRALOrder Code Description Dimensions Qty

VTX1515M Versatex™ Monofilament Mesh Square 15 x 15 cm box of 1

VTX1515MX3 Versatex™ Monofilament Mesh Square 15 x 15 cm box of 3

VTX2020M Versatex™ Monofilament Mesh Square 20 x 20 cm box of 1

VTX3030M Versatex™ Monofilament Mesh Square 30 x 30 cm box of 1

VTX4530M Versatex™ Monofilament Mesh Rectangular 45 x 30 cm box of 1

VTX5050M Versatex™ Monofilament Mesh Square 50 x 50 cm box of 1

VERSATEX™ MONOFILAMENT MESH

Page 6: MUCH MORE THAN A MESH - Medtronic

The truly tension-free choice13

■ Bicomponent construct of monofilament PET knit with resorbable Polylactic Acid (PLA) micro-grips

■ Self-gripping fixation over 100% of surface area

■ Surface Density of 73.0 g/m2 (before PLA resorption); 38.0 g/m2 (after PLA resorption)

■ Pore size of 1.1 mm to 1.7 mm

Ordering InformationINGUINALOrder Code Description Dimensions Qty

TEM1208GL ProGrip™ Self-Gripping Polyester Mesh 12 x 8 cm box of 1

TEM1208GR ProGrip™ Self-Gripping Polyester Mesh 12 x 8 cm box of 1

TEM1409GL ProGrip™ Self-Gripping Polyester Mesh 14 x 9 cm box of 1

TEM1409GR ProGrip™ Self-Gripping Polyester Mesh 14 x 9 cm box of 1

VENTRALOrder Code Description Dimensions Qty

TEM1515G ProGrip™ Self-Gripping Polyester Mesh 15 x 15 cm box of 1

TEM2015G ProGrip™ Self-Gripping Polyester Mesh 20 x 15 cm box of 1

TEM3015G ProGrip™ Self-Gripping Polyester Mesh 30 x 15 cm box of 1

PROGRIP™ SELF-GRIPPING POLYESTER MESH

Page 7: MUCH MORE THAN A MESH - Medtronic

References

1. Based on internal test report #T2306CR062a/TEX044d evaluating 3DS/3DV textile characterization. April 2015.

2. Deeken CR, Abdo MS, Frisella MM, Matthews BD. Physicomechanical evaluation of polypropylene, polyester, and polytetrafluoroethylene meshes for inguinal hernia repair. J Am Coll Surg. 2011;212(1):68-79.

3. Lake S, Ray S, Zihni AM, Thompson DM Jr, Gluckstein J, Deeken CR. Pore size and pore shape – but not mesh density — alter the mechanical strength of tissue ingrowth and host tissue response to synthetic mesh materials in a porcine model of ventral hernia repair. J Mech Behav Biomed Mater. 2015;42:186-197.

4. Based on Versatex™ monofilament mesh IFU.

5. Wehye D, Cobb W, Lecuivre J, et al. Large pore size and controlled mesh elongation are relevant predictors for mesh integration quality and low shrinkage -Systematic analysis of key parameters of meshes in a novel minipig hernia model*. Int J Surg. 2015;22:46-53.

6. Based on internal test report #T2306CR022a assessing safety and local tolerance. October 2014.

7. Based on internal test report #T2306CR042b assessing physical and mechanical properties of Versatex™ vs. current meshes on the market. April 2015.

8. Weyhe D, Schmitz I, Bellyaev O, et al. Experimental comparison of monofile light and heavy polypropylene meshes: less weight does not mean less biological response. World J Surg. 2006;30(8):1586-91.

9. Klosterhalfen B, Klinge U. Retrieval study at 623 human mesh explants made of polypropylene–impact of mesh class and indication for mesh removal on tissue reaction. J Biomed Mater Res B Appl Biomater. 2013;101(8):1393-9.

10. Hollinsky C, Kolbe T, Walter I, et al. Comparison of a new self-gripping mesh with other fixation methods for laparoscopic hernia repair in a rat model. J Am Coll Surg. 2009;208(6):1107– 1114. This study was conducted with Parietene ProGrip™ mesh.

11. Weyhe D, Cobb W, Lecuivre J, et al. Large pore size and controlled mesh elongation are relevant predictors for mesh integration quality and low shrinkage: systematic analysis of key parameters of meshes in a novel minipig hernia model. Int J Surg. 2015;22:46–53.

12. Ventral Hernia Working Group, Breuing K, Butler CE, Ferzoco S, et al. Incisional ventral hernias: Review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010;148(3):544–558.

13. Based on internal test report #TEX014f, physical and mechanical characterization of ProGrip™ Self-Gripping Mesh Textile with Grips from 2015.

14. Agarwal BB, Agarwal KA, Mahajan KC. Prospective double-blind randomized controlled study comparing heavy and lightweight polypropylene mesh in totally extraperitoneal repair of inguinal hernia: early results. Surg Endosc. 2009;23(2):242–7.

15. Based on Versatex™ monofilament mesh evaluation by surgeons for design validation. Internal report #T2306CR053b. March 2015.

16. Kapischke M, Schulze H, Caliebe A. Self-fixating mesh for the Lichtenstein procedure: a prestudy. Langenbecks Arch Surg. 2010;395(4):317–322. This study was conducted with Parietene ProGrip™ mesh.

17. Chastan P. Tension free open inguinal hernia repair using an innovative self-gripping semi-resorbable mesh. Hernia (2009) 13:137–142 DOI 10.1007/s10029-008-0451-4 J Minim Access Surg. 2006;2(3):139–143. This study was conducted with Parietene ProGrip™ mesh.

18. Bringman S, Wollert S, Osterberg J, et al. Three-year results of a randomized clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia. Br J Surg. 2006;93(9):1056-9.

19. Based on internal test report #T2291CR059a, Parietene™ macroporous mesh (type P12 textile) vs. Prolene™* soft polypropylene mesh. May 12, 2014.

20. Based on internal test report #T2291CR044, Physical and mechanical properties of Parietene™ macroporous mesh.

21. Based on internal test report #T2291CR037, Parietene™ macroporous mesh evaluation by surgeons for design validation. June 13, 2014.

22. Based on internal test report #T2291CR050a, Designed for improved visualization during placement. July 23, 2014.

Page 8: MUCH MORE THAN A MESH - Medtronic

IMPORTANT: Please refer to the package insert for complete instructions, contraindications, warnings and precautions.

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