Smith+Nephew announces new milestone with its OXINIUM™ Advanced Bearing System implants surpassing two million procedures

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Smith & Nephew plc

Jun 18, 2020, 08:00 ET

LONDON, June 18, 2020 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, today announced that over two million patients have been treated with implants made from OXINIUM Technology - a proprietary oxidized zirconium alloy used in hip and knee replacements.

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Smith+Nephew's OXINIUM Technology
Smith+Nephew's OXINIUM Technology

OXINIUM is a unique material that combines the strength of metal with the wear resistance of ceramic. Its hardness, low-friction and resistance to roughening and abrasion makes it ideal for a wide variety of hip and knee applications. OXINIUM's combination of long-term durability and wear resistance has propelled Smith+Nephew's reconstruction portfolio over the last two decades.

"Smith+Nephew is proud to have an extensive history of innovation, highlighted by one of the flagship bearing materials in all of orthopaedics. OXINIUM has helped over two million patients get back on their feet and we look forward to seeing millions more live their life unlimited in the future," said Randy Kilburn, Smith+Nephew Senior Vice President of Global and Commercial Marketing, Orthopaedics.

The evidence speaks for itself:

  • Four major registries around the world have shown OXINIUM to be the best performing hip bearing on the market.1-4
  • From three months on, OXINIUM Technology with XLPE significantly reduces the revision risk in total hip arthroplasty by 29% compared to Metal/XLPE (p<0.001).1
  • The only bearing technology with published results of 45 Million Cycles knee in vitro wear simulation testing, simulating 30 years of normal activity.5,6
  • Over 34 published studies showing excellent long-term survivorship, including lower damage scores in knee retrieval analysis, and better results when compared to cobalt chrome.7,8

OXINIUM Technology is a key component in several advanced products offered through Smith+Nephew's innovative hip and knee portfolios:

  • POLAR3™ Total Hip Solution - The combination of POLARSTEM™ cementless stem and the R3™ Acetabular System, featuring the proprietary OXINIUM™ oxidized zirconium on XLPE bearing couple, that provides improved patient reported outcomes with high survivorship at eight years.9
  • OR3O™ Dual Mobility System - Utilizing new OXINIUM™ DH (Diffusion Hardened) Technology, the OR3O dual mobility hip system is designed to minimize corrosion concerns, maximize stability and reduce the risk of dislocation.
  • JOURNEY™ II Total Knee System - Designed to replicate normal anatomy and help patients rediscover normal through smoother recovery10, improved function11-14 and higher patient satisfaction.10,11,15,16
  • JOURNEY II Unicompartmental Knee - Next generation unicondylar platform that leverages strong clinical history with modernized instrumentation and OXINIUM Technology.1,17,18

"I have been using OXINIUM for the last 15 years. Polyethylene wear and trunnion issues do not exist in my practice. Global clinical data continues to support excellent results of Smith+Nephew implants with OXINIUM technology," said Alvin Ong, MD, Orthopedic Surgeon at the Rothman Institute.

Introduced in 1995, OXINIUM Technology has nearly 25 years of clinical heritage and is one of the many innovations driving Smith+Nephew's advanced hip and knee portfolio. In 2005, OXINIUM Technology was the first and only medical device material to receive the prestigious Engineering Achievement Materials Award from ASTM International.

References

  1. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip, Knee & Shoulder Arthroplasty: 2019 Annual Report. Adelaide: AOA, 2019. Accessed March 30, 2020.
  2. Atrey A, Ancarani C, Fitch D, Bordini B. Impact of bearing couple on long-term component survivorship for primary cementless total hip replacement in a large arthroplasty registry. Poster presented at: Canadian Orthopedic Association; June 20–23, 2018; Victoria, British Columbia, Canada.
  3. Peters RM, Van Steenbergen LN, Stevens M, Rijk PC, Bulstra SK, Zijlstra WP. The effect of bearing type on the outcome of total hip arthroplasty. Acta Orthop. 2018:89;163–169.
  4. Davis ET, Pagkalos J, Kopjar B. Bearing surface and survival of cementless and hybrid total hip arthroplasty in the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man. JBJS OA. 2020;5:e0075.
  5. The LEGION™ Primary CR Knee System completed 45 million cycles of in vitro simulated wear testing, which is an estimate of 30 years of activity. Other LEGION VERILAST Primary Knee Systems underwent similar lab testing comparable to industry standards. The results of in vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in improved clinical outcomes as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of the testing.
  6. Papannagari, R, Hines G, Sprague J, Morrison M, Long-term wear performance of an advanced bearing knee technology.  ISTA, Dubai, UAE, Oct 6-9, 2010.
  7. Civinini, R, Matassi F, Carulli C, Sirleo L, Cozzi Lepri A, Innocenti M. Clinical Results of Oxidized Zirconium Femoral Component in TKA. A Review of Long-Term Survival. HSS Journal 2017; 13:32–34
  8. Heyse TJ, Chen DX, Kelly N, et al. Matched-pair total knee arthroplasty retrieval analysis:Oxidized zirconium vs. CoCrMo. The Knee. 2011;18:448-452.
  9. National Joint Registry for England, Wales and Northern Ireland: POLARSTEM Cementless (Oxinium/XLPE/R3 cup) implant summary report. 14 August 2019. Available at: http://bit.ly/POLAR3_Aug2019.
    †The data used for this analysis was obtained from the NJR Supplier Feedback System. The Healthcare Quality Improvement Partnership ("HQIP") and/or the National Joint Registry ("NJR") take no responsibility for the accuracy, currency, reliability and correctness of any data used or referred to in this report, nor for the accuracy, currency, reliability and correctness of links or references to other information sources and disclaims all warranties in relation to such data, links and references to the maximum extent permitted by legislation.
  10. Mayman DJ, Patel AR, Carroll KM. Hospital Related Clinical and Economic Outcomes of a Bicruciate Knee System in Total Knee Arthroplasty Patients. Poster presented at: ISPOR Symposium; May 19-23, 2018; Baltimore, Maryland, USA.
  11. Nodzo SR, Carroll KM, Mayman DJ. The Bicruciate Substituting Knee Design and Initial Experience. Tech Orthop. 2018;33:37-41.
  12. Takubo A, Ryu K, Iriuchishima T, Tokuhashi Y. Comparison of muscle recovery following bicruciate substituting versus posterior stabilized total knee arthroplasty in an Asian population. J Knee Surg. 2017;30:725–729.
  13. Kosse NM, Heesterbeek PJC, Defoort KC, Wymenga AB, van Hellemondt GG. Minor adaptations in implant design bicruciate-substituted total knee system improve maximal flexion. Poster presented at: 2nd World Arthroplasty Congress; 19-21 April, 2018; Rome, Italy.
  14. Murakami K, Hamai S, Okazaki K, et al. In vivo kinematics of gait in posterior-stabilized and bicruciate-stabilized total knee arthroplasties using image-matching techniques. Int Orthop. 2018;42:2573-2581.
  15. Walker LC, Clement ND, Bardgett M, et al. The WOMAC score can be reliably used to classify patient satisfaction after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2018;26:3333–3341.
  16. Noble PC, Scuderi GR, Brekke AC, et al. Development of a New Knee Society Scoring System. Clin Orthop Relat Res. 2012;470:20–32.
  17. Smith&Nephew. May 2019. ZUK systematic review of clinical outcomes: systematic literature review and meta-analysis. Report reference 16121_US 1 V1.
  18. Smith&Nephew. Sept. 2015. The ZUK Unicompartmental Knee: A Systematic Literature Review of Clinical Outcomes and a Supplementary Analysis of its Predecessor Device. Bone&JointOutcome. Report reference 04234 V1

About Smith+Nephew

Smith+Nephew is a portfolio medical technology business that exists to restore people's bodies and their self-belief by using technology to take the limits off living. We call this purpose 'Life Unlimited'. Our 17,500+ employees deliver this mission every day, making a difference to patients' lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT.

Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.1 billion in 2019. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms 'Group' and 'Smith+Nephew' are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on Twitter, LinkedIn, Instagram or Facebook.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.

™ Trademark of Smith+Nephew. Certain marks registered US Patent and Trademark Office.

SOURCE Smith & Nephew plc

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