E1™ Antioxidant Infused Technology - Biomet

E1™ Antioxidant Infused Technology - Biomet E1™ Antioxidant Infused Technology - Biomet

E1 <br />

<strong>Antioxidant</strong><br />

<strong>Infused</strong> <strong>Technology</strong><br />

Knees • Hips • Extremities • Cement and Accessories • PMI ® • <strong>Technology</strong>


E1 <br />

<strong>Antioxidant</strong> <strong>Infused</strong> <strong>Technology</strong><br />

<strong>Infused</strong> with vitamin E, a natural<br />

antioxidant, E1 <strong>Technology</strong> defines a<br />

new class of bearings and overcomes<br />

the limitations of remelted and annealed<br />

polyethylenes by uniting true oxidative<br />

stability, high mechanical strength and<br />

ultra low wear. 1,2<br />

Oxidative Stability<br />

Testing has shown that vitamin E prevents<br />

oxidative degradation of the polyethylene<br />

without remelting, allowing the material to<br />

maintain mechanical properties and wear<br />

resistance over time. 1<br />

0.8<br />

Oxidation Profile 1,3<br />

After ESC testing<br />

0.7<br />

Oxidation Index (Absorbance Units)<br />

0.6<br />

0.5<br />

0.4<br />

0.3<br />

0.2<br />

0.1<br />

0.0<br />

-0.1<br />

Top<br />

Surface<br />

Center<br />

Bottom<br />

Surface<br />

Sequentially Crosslinked and Annealed Loaded<br />

Sequentially Crosslinked and Annealed Control<br />

E1 Material Loaded<br />

E1 Material Control<br />

Mechanical Strength<br />

E1 material is never remelted<br />

and therefore maintains its strength. 1,2<br />

It is also stronger than sequentially<br />

crosslinked and annealed materials after<br />

fatigue testing in an accelerated aging<br />

environment (environmental stress<br />

crack testing). 1<br />

Ultra Low Wear<br />

10 Mrad (100 kGy) irradiation results<br />

in high levels of crosslinking for<br />

wear resistance. 1<br />

87 percent (posterior<br />

stabilized) wear reduction<br />

over conventional Direct<br />

Compression Molded<br />

polyethylene in the knee 1


Ultra Low Wear<br />

50<br />

Volumetric Wear Rates<br />

of Largest Cruciate Retaining (CR)<br />

Tibial Bearing Profile 1<br />

Tested at <strong>Biomet</strong> Biomaterials Laboratory<br />

43.4<br />

40<br />

89 percent wear reduction with<br />

large heads when compared to<br />

ArComXL ® Polyethylene in the hip 1<br />

Volumetric Wear Rate<br />

(mm 3 /MC)<br />

30<br />

20<br />

86% CR wear<br />

reduction<br />

over Direct<br />

Compression<br />

Molded<br />

10<br />

6.1<br />

0<br />

DCM<br />

UHMWPE<br />

E1 <br />

Material<br />

25<br />

Volumetric Wear Rates<br />

of Largest Posterior Stabilized (PS)<br />

Tibial Bearing Profile 1<br />

Tested at University of Nebraska<br />

21.33<br />

20<br />

Volumetric Wear Rate<br />

(mm 3 /MC)<br />

15<br />

10<br />

5<br />

87% PS wear<br />

reduction<br />

over Direct<br />

Compression<br />

Molded<br />

2.87<br />

0<br />

DCM<br />

UHMWPE<br />

E1 <br />

Material<br />

30<br />

27.44<br />

Volumetric Wear Rates<br />

of 38mm Acetabular Liners 1<br />

5 Million Cycles<br />

38mm Head Size<br />

25<br />

Volumetric Wear Rate<br />

(mm 3 /MC)<br />

20<br />

15<br />

10<br />

15.62<br />

89% large<br />

head wear<br />

reduction over<br />

ArComXL ®<br />

Polyethylene<br />

5<br />

0<br />

CoCr/ BIOLOX ®<br />

ArComXL ® delta/<br />

Polyethylene ArComXL ®<br />

Polyethylene<br />

3.16<br />

CoCr/<br />

E1 <br />

Material<br />

1.71 1.37<br />

BIOLOX ®<br />

delta/<br />

E1 <br />

Material<br />

Metal-on-<br />

Metal<br />

(Run-in Wear)<br />

1


E1 <strong>Technology</strong> and the Vanguard ® Complete Knee<br />

E1 Tibial Bearings<br />

Vanguard ® Complete Knee System<br />

• Five primary articulations*<br />

(see adjacent graphics)<br />

• Patented 1:1 conformity in coronal plane:**<br />

allows unlimited femoral/tibial sizing options<br />

• Patellar tendon relief facilitates increased<br />

range of motion<br />

• Compressively loaded tibial locking<br />

mechanism provides proven resistance<br />

to tibial micromotion 4<br />

* Articulation availability may vary by region. Please contact your<br />

local <strong>Biomet</strong> Representative for details.<br />

**U.S. Patent No. 5,330,534<br />

Ultimate Tensile and Yield Strengths<br />

for Multiple Polyethylenes 1,5<br />

50<br />

40<br />

48.1<br />

40.8<br />

45.8<br />

46.1<br />

Tensile<br />

Strength (MPa)<br />

Yield<br />

Strength (MPa)<br />

Tensile Strength (MPa)<br />

30<br />

20<br />

20.1<br />

21.3<br />

22.6<br />

22.8<br />

33.3<br />

19.0<br />

10<br />

0<br />

DCM Unaged 1 DCM Aged 1 E1 <br />

Material<br />

Unaged 1<br />

E1 <br />

Material<br />

Aged 1<br />

100kGy<br />

Remelted 5<br />

2


System<br />

E1 Tibial<br />

Bearing Options<br />

Cruciate Retaining<br />

• 3 degrees posterior slope<br />

• 15 degrees internal/external rotation<br />

Cruciate Retaining Lipped<br />

• Enhanced posterior lip<br />

• 15 degrees internal/external rotation<br />

Anterior Stabilized<br />

• Prominent 10mm anterior lip<br />

• 5mm posterior lip<br />

• 6 degrees internal/external rotation<br />

Posterior Stabilized<br />

• No varus/valgus constraint<br />

• 15 degrees internal/external rotation<br />

Posterior Stabilized Plus<br />

• 2 degrees varus/valgus constraint<br />

• +/- 2 degrees internal/external rotation<br />

3


E1 <strong>Technology</strong> and the Taperloc ® Microplasty ® Hip<br />

E1 Acetabular Liners<br />

RingLoc ® + Modular Acetabular System<br />

• Five liner configurations available from<br />

28–40mm inner diameters<br />

(see adjacent graphics)<br />

• Can be used with large femoral heads for<br />

optimal joint stability and range of motion<br />

• BIOLOX ® delta ceramic heads on E1 <br />

bearings reduce wear by 46 percent over<br />

cobalt chrome heads 1<br />

Ultimate Tensile and Yield Strengths<br />

for Multiple Polyethylenes 1,5–6<br />

50<br />

40<br />

43<br />

Tensile<br />

Strength (MPa)<br />

Yield<br />

Strength (MPa)<br />

Tensile Strength (MPa)<br />

30<br />

20<br />

24.2<br />

33<br />

19<br />

34<br />

21<br />

10<br />

0<br />

E1 <br />

Material 1<br />

100kGy<br />

Remelted 5<br />

50kGy<br />

Remelted 6<br />

4


System<br />

E1 Acetabular<br />

Liner Options<br />

Max-Rom + Liner<br />

• Maximizes range of motion<br />

• Allows for a 36mm head in a 50mm cup<br />

Hi-Wall+ Liner<br />

• Added lip offers additional joint stability<br />

• Allows for a 36mm head in a 50mm cup<br />

10-Degree Liner<br />

• 10 degree angled face offers additional<br />

joint stability<br />

• Reduces the angle of a vertical liner<br />

+5mm Hi-Wall Liner<br />

• Added lip offers additional joint stability<br />

• 5mm offset for joint restoration in<br />

revision cases<br />

+5mm Liner<br />

• Maximizes range of motion<br />

• 5mm offset for joint restoration in<br />

revision cases


References<br />

1. Data on file at <strong>Biomet</strong>. Bench test results not necessarily indicative<br />

of clinical performance.<br />

2. Kurtz, S. et al. The UHMWPE Handbook: Ultra High Molecular<br />

Weight Polyethylene in Total Joint Replacement. Elsevier Academic<br />

Press. San Diego, CA. 2004.<br />

3. Nabar, S. et al. Comparison of Second Generation Highly Crosslinked<br />

Polyethylenes Under Adverse Aging Conditions. ORS 2008. Poster<br />

No. 1684.<br />

4. Parks, N.L. et al. Modular Tibial Insert Micromotion: A Concern with<br />

Contemporary Knee Implants. Clinical Orthopaedics and Related<br />

Research. 356: 10–15, 1998.<br />

5. Bhambri, S. et al. The Effect of Aging on Mechanical Properties<br />

of Melt-annealed Highly Crosslinked UHMWPE. Crosslinked and<br />

Thermally Treated Ultra-High Molecular Weight Polyethylene for<br />

Joint Replacements. 171–82, 2004.<br />

6. Greer, K.W. et al. The Effect of Raw Material, Irradiation Dose, and<br />

Irradiation Source on Crosslinking of UHMWPE. Crosslinked and<br />

Thermally Treated Ultra-High Molecular Weight Polyethylene for<br />

Joint Replacements. 290–20, 2004.<br />

BIOLOX ® delta is a trademark of CeramTec AG.<br />

All trademarks herein are the property of <strong>Biomet</strong>, Inc. or its subsidiaries unless<br />

otherwise indicated.<br />

This material is intended for the sole use and benefit of the <strong>Biomet</strong> sales force and<br />

physicians. It is not to be redistributed, duplicated or disclosed without the express<br />

written consent of <strong>Biomet</strong>.<br />

For product information, including indications, contraindications, warnings,<br />

precautions and potential adverse effects, see the product-specific package inserts<br />

and <strong>Biomet</strong>’s website.<br />

ORTHOPEDICS<br />

SM<br />

One Surgeon. One Patient.<br />

P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 x 1501<br />

©2008, 2009 <strong>Biomet</strong> Orthopedics • www.biomet.com<br />

Form No. BOI0314.1 • REV103109

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