E1™ Antioxidant Infused Technology - Biomet
E1™ Antioxidant Infused Technology - Biomet E1™ Antioxidant Infused Technology - Biomet
E1 Antioxidant Infused Technology Knees • Hips • Extremities • Cement and Accessories • PMI ® • Technology
- Page 2 and 3: E1 Antioxidant Infused Technology
- Page 4 and 5: E1 Technology and the Vanguard ®
- Page 6 and 7: E1 Technology and the Taperloc ®
- Page 8: References 1. Data on file at Biome
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