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DePuy Synthes Companies Announces New ATTUNEĀ® Revision Fixed Bearing Tibial Base and Cemented Stem for Primary and Revision Surgeries

Vienna, Austria, 1 June 2017 – Today DePuy Synthes, part of the Johnson & Johnson Family of Companies, announced the Europe, Middle East and Africa launch of the first ATTUNE® Knee revision options, the ATTUNE Revision Fixed Bearing Tibial Base and the 14x50 mm Cemented Stem. The Tibial Base is designed to address a range of patient needs, from complex primary to partial revision of ATTUNE Primary Knees.The announcement was made in Vienna, coinciding with the 18thEuropean Federation of National Associations of Orthopaedics and Traumatology (EFORT) congress.

The ATTUNE Revision Fixed Bearing Tibial Base, which is compatible with either fixed bearing posterior stabilized or cruciate retaining tibial inserts, incorporates the proprietary technologies of the ATTUNE Knee such as the LOGICLOCK™ Tibial Base locking mechanism that is designed to enable enhanced kinematics, stability and wear reduction.1 The ATTUNE Revision Fixed Bearing Tibial Base can be used with a 14x50 mm Cemented Stem that can be added intra-operatively at the discretion of the surgeon for patients with clinical needs that require supplemental fixation.

According to Rajit Kamal, Global Knee Platform Leader, DePuy Synthes Joint Reconstruction, “DePuy Synthes worked with renowned experts around the world to develop the ATTUNE Knee System. The ATTUNE Revision Fixed Bearing Tibial Base and Cemented Stem were developed to address more complex clinical needs and expand treatment options for patients, broadening DePuy Synthes portfolio of revision solutions.”

DePuy Synthes Companies developed the ATTUNE Knee System to improve the stability and motion of knee replacement, which are important to patient satisfaction. Emerging evidence suggests that the ATTUNE Knee System could help patients return to their normal activities sooner than anticipated2-3, while also enabling surgeons and healthsystems to improve clinical outcomes, reduce costs and increase patient satisfaction.3-6,

In addition, DePuy Synthes announced yesterday new ATTUNE® Knee implant survivorship data based on an Implant Summary Report obtained from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR).  The independent analysis of 10,605 ATTUNE Knee implantations, showed that the cumulative revision rate for the ATTUNE Knee is 1.3% at four years (98.7% implant survivorship at four years), compares favorably to the 1.9% cumulative revision rate (98.1% implant survivorship at four years) for the overall class of total knee replacement.7 

Of the 10,605 ATTUNE Knees included in the analysis, 46 required revision. Based on a separate analysis within the report, the NJR concluded that 63 ATTUNE Knee revisions would be expected at four years – a difference that was statistically significant (p<0.05).7 The expected number of ATTUNE Knee revisions was calculated by the NJR based on duration of implantation, age group, gender and indications.

These data add to the body of evidence on the positive performance of the ATTUNE Knee but cannot be extrapolated to include the ATTUNE Revision Fixed Bearing Tibial Base, as it is both new and may treat additional patient populations not included in the above report.

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit  www.depuysynthes.com .

Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the effectiveness and value of theATTUNE Knee System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns for health care products and services; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements”, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at  www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

The third party trademarks used herein are the trademarks of their respective owners.

©Johnson & Johnson Medical Limited. 2017. All rights reserved.

Registered Office: Johnson & Johnson Medical Limited, PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom.  Incorporated and registered in Scotland under company number SC132162

References:
 

  1. Leisinger, S., Hazebrouck, S., Deffenbaugh, D., Heldreth, M. (2011) Advanced fixed bearing TKA locking mechanism minimizes backside micromotion. International Society for Technology in Arthroplasty (ISTA) Annual Meeting.
  2. Clatworthy, M. (2015). An Early Outcome Study of the ATTUNE® Knee System vs. the SIGMA® CR150 Knee System. DePuy Synthes Companies White Paper. DSUS/JRC/0814/0418.

In an IRB approved early outcomes study, physiotherapists collected data on 40 patients implanted with ATTUNE® Knees and 40 patients with SIGMA® CR150 knees. The results demonstrated that patients implanted with the ATTUNE Knee had statistically significant improvements in some early outcomes, other outcomes demonstrated a trend favoring the ATTUNE Knee, and some outcomes were equivalent

  1. Etter, K., Lerner, J., de Moor, C, Yoo, A., Kalsekar, I. (2016). PMD10-Comparative Effectiveness of ATTUNE® Versus Triathlon™ Total Knee Systems: Real-World Length of Stay and Discharge Status." Value in Health 19(3): A298.

Premier Perspective™ Database analysis including 38 hospitals, representing 1,178 primary, unilateral TKAs with the ATTUNE Knee and 5,707 primary, unilateral TKAs with Triathlon™. The analysis found that the patients implanted with the ATTUNE Knee had statistically shorter length of stay and were more frequently discharged home vs. a skilled nursing facility compared to the TKAs with Triathlon™.

  1. Australian Orthopaedic Association National Joint Replacement Registry Annual Report. (2016). Tables KT9 and KT22. Retrieved from: https://aoanjrr.sahmri.com/documents/10180/275066/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty

  2. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man Annual Report. (2016). Tables 3.28 and 3.24 (a). Retrieved from: http://www.njrcentre.org.uk/njrcentre/Portals/0/Documents/England/Reports/13th%20Annual%20 Report/07950%20NJR%20Annual%20Report%202016%20ONLINE%20REPORT.pdf
  3. Hamilton WG, Brenkel I, Clatworthy M, Dwyer K, Himden S, Lesko J, Kantor S. Early Patient-Reported Outcomes With Primary vs Contemporary Total Knee Arthroplasty: A Comparison of Two Worldwide Multi-Center Prospective Studies. Presentation at the International Society for Technology in Arthroplasty (ISTA), Boston, MA Oct. 2016. Poster Presentation & E-Poster 0060.
  4. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Summary Report for DePuy ATTUNE CR and ATTUNE PS. NJR Database extract April 7, 2017, pages 1-17. Licensed for use until April 19, 2018. Available at  www.provingthepromise.com

    DSEM/JRC/0317/0786
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