Vivacit-E® Vitamin E Highly Crosslinked Polyethylene

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Zimmer Biomet developed Vivacit-E® Vitamin E Highly Crosslinked Polyethylene with antioxidant protection to meet the long-term performance needs of high demand patients. Building on the legacy of Longevity® Highly Crosslinked Polyethylene with more than 13 years of clinical success1, our proprietary process results in:

Oxidative Stability2

It’s widely accepted that oxidation is a primary aging mechanism of polyethylene, which can lead to osteolysis and implant failure.12 The oxidative stability of Vivacit-E HXPE is the result of a proprietary process that grafts (locks) Vitamin E directly to the polyethylene chain.6-9 The Vitamin E continuously stabilises the material to prevent oxidative degradation of the polyethylene. When subjected to accelerated aging for 33 weeks (16 times the industry standard), Vivacit-E HXPE showed no signs of oxidation or significant decline in mechanical properties.2

Ultra-low Wear3

The ultra-low wear rates of Longevity liners have been well established over 13 years of clinical history.1 Tests conducted on 2 week-aged 40mm articulation size Vivacit-E liners and Longevity liners, Vivacit-E liners showed ultra-low wear rates comparable to Longevity liners.3

To prove Vivacit-E HXPE’s long-term ultra-low wear properties a wear test was run out to 100 million cycles. The test proved Vivacit-E HXPE has ultra-low wear properties even after long-term simulator testing.10

Improved Strength4,5

There are many tests to define a material’s strength. Zimmer Biomet has realised an improvement in tensile strength with Vivacit-E HXPE. Vivacit-E HXPE has antioxidant protection that eliminates the need to re-melt the polyethylene, leading to an improvement in strength. The Vitamin E in Vivacit-E HXPE prevents oxidation, resulting in mechanical strength that is retained after accelerated aging for more than 16 times the 2week industry standard test according to ASTM F2003.2,4,11

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References

Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners were cleared with the following performance claims:

FDA Traditional 510(k) K120370

Vivacit-E Performance Claims

 

  1. Bragdon, C. et al. Clinical Multicenter Studies of the Wear Performance of Highly Crosslinked Remelted Polyethylene in THA. Clin Orthop Relat Res (2013) 471:393-402.
  2. Pletcher, D. et al. Vitamin E Grafted HXPE Shows Superior Mechanical Property Retention Compared to Conventional UHMWPE and Sequentially Annealed HXP.  Poster No. 1868, ORS 2014 Meeting.
  3. Zimmer ZRR _WA_2512_12
  4. Zimmer ZRR _WA_2401_11, Rev. 1
  5. Peiserich, M. et al. Retention of Mechanical Properties in a Blended Vitamin E Polyethylene After Extreme Oxidative Challenge. ORS 2013. Poster 1060.
  6. Oral, E. et, al. Crosslinked Vitamin E Blended UHMWPE with Improved Grafting and Wear Resistance. Poster No. 1181. ORS 2011 Meeting.
  7. Oral, E. et, al. Trace amounts of grafted vitamin E protect UHMWPE against squalene-initiated oxidation. Poster No. 1295. ORS 2011 Meeting
  8. Rowell, S. et, al. Detection of Vitamin E in Irradiated UHMWPE by UV-Visible Spectroscopy. Poster No. 1186. ORS 2011 Meeting.
  9. Wolf, C. et, al. Radiation Grafting of Vitamin E to Ultra High Molecular Weight Polyethylene. Poster No. 1178. ORS 2011 Meeting.
  10. Zimmer ZRR_WA_3036_15
  11. Zimmer TM1140.98

 

Note: Bench testing is not necessarily indicative of clinical performance.

 

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Zimmer, Inc.
1800 West Center Street
Warsaw, Indiana 46580 USA

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