Johnson & Johnson MedTech* has today announced that DePuy Synthes,** The Orthopaedics Company of Johnson & Johnson, is adding two new innovations to its kinematically advanced and proveni,ii,iii,iv,v,vi ATTUNE™ Knee portfolio: the ATTUNE™ Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP Technology and the ATTUNE™ Medial Stabilized Knee System.
Approximately 20 percent of Total Knee Arthroplasty (TKA) patients are dissatisfied with their results.vii The biggest challenges reported are functional activities beyond walking, such as kneeling or getting in-out of a car.vii,viii The ATTUNE Knee is already addressing the 20 percent gap by delivering significantly better patient satisfaction than other knees in the same classix and has demonstrated implant survivorship within class.x,xi,xii,xiii,xiv
These new innovations build on the kinematic features and proprietary technologies of the original ATTUNE Knee, including the ATTUNE GRADIUS™ Curve and GLIDERIGHT™ Articulation, which are designed to revolutionize knee patient care.
ATTUNE™ Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP Technology
Introduced in late 2021, the ATTUNE Cementless Fixed Bearing Knee with AFFIXIUM 3DP Technology (ATTUNE AFFIXIUM Knee) is a next generation, 3D printed cementless knee designed for a growing population of more active patients for whom biological fixation helps to better meet the demands of their active lifestyle today and into the future. The ATTUNE AFFIXIUM Knee is the first in the ATTUNE Knee portfolio to utilize this advanced 3D printing technology, which creates a three-dimensional lattice structure, generating a similar porosity to natural bone for advanced biological fixationxv and helps enhance initial implant stability.xvi
“The ATTUNE AFFIXIUM Knee is a game changer for patients,” said Dr. Ryan Nunley,*** orthopaedic surgeon, St. Louis, MO. “The porous nature more naturally represents bone structure, which I believe helps with initial implant stability. Cementless fixation is growing quickly, and this is a phenomenal opportunity for advancing patient care.”
The ATTUNE AFFIXIUM Knee follows the 2019 launch of the ATTUNE Rotating Platform Cementless Knee which utilizes POROCOAT™ Porous Coating for cementless application.
ATTUNE Medial Stabilized Knee System
Designed to meet patients’ needs for improved feel and function, DePuy Synthes has also introduced the ATTUNE Medial Stabilized Knee System, which incorporates asymmetric anatomic inserts with a raised medial lip, to provide medial stabilityxvii and a TruARC™ Lateral Path for natural knee function.xvii,xviii,xix The versatility of the system addresses a range of posterior cruciate ligament (PCL) management and surgical philosophies.xx More than just an insert, the ATTUNE Medial Stabilized Knee System brings together the ATTUNE GRADIUS Curve and the LOGICLOCK™ Tibial base, to restore natural knee kinematics.xvii,xviii,xix
“We are truly entering the next phase in knee replacement surgery – knee restoration,” said Dr. Jonathan Vigdorchik,**** orthopaedic surgeon, New York, NY. “The ATTUNE Medial Stabilized Knee System is the perfect complement to the ATTUNE Knee platform and provides my patients with the medial conformity and lateral rollback that I want so that their knee feels more natural.”
Both the ATTUNE AFFIXIUM Knee and the ATTUNE Medial Stabilized Knee System work seamlessly with the innovative VELYS™ Robotic-Assisted Solution, which helps surgeons provide a tailored experience intraoperatively based on each patient’s anatomy. The precision and reliability of robotic-assisted bone cuts means the surgeon can accommodate patient-specific surgical techniques and control the implant position and fit for each patient.
“Through our DePuy Synthes Knee Solutions, we’re revolutionizing the traditional approach to total knee arthroplasty by offering patients a tailored surgical experience based on the combination of our kinematically advanced implants, our differentiated digital technology, and patient-specific techniques,” said Juston Gates,***** Worldwide Vice President of Knee Reconstruction for DePuy Synthes. “We believe that this combination can lead to knee restoration and with it, we envision a future of better outcomes and improved patient satisfaction.”
To learn more about these enhancements and how they could improve care for patients, please visit kneerestoration.com.
* Comprising the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
** DePuy Synthes represents the products and services of DePuy Synthes Sales, Inc. and its affiliates.
*** Dr. Ryan Nunley is a design surgeon and paid consultant of an affiliate of DePuy Synthes.
**** Dr. Jonathan Vigdorchik is a design surgeon and a paid consultant of an affiliate of DePuy Synthes.
*****Juston Gates is an employee of Medical Device Business Services, Inc.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the ATTUNE™ Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP Technology and the ATTUNE Medial Stabilized 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, Inc, any of the other Johnson & Johnson MedTech Companies 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; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions 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 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other 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, Inc. / the Johnson & Johnson MedTech Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Source: DePuy Synthes
Please refer to the instructions for use for a complete list of indications, contraindications, warnings and precautions.
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ii Indelli PF, Pipino G, Johnson P, Graceffa A, Marcucci M. Posterior-stabilized total knee arthroplasty: a matched pair analysis of a classic and its evolutional design. Arthroplasty Today 2016;2(4):193-198.
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v Hamilton W, Brenkel I, Barnett S, et al. Comparison of P.F.C. SIGMA to ATTUNE: A Prospective, Multicenter Study. Podium Presentation at the Closed Meeting of the Knee Society, Sept 2018, St Louis, MO, USA. 2018.
vi Etter K, LB, Chesworth B, Davis A, Mahomed N, Charron K. Comparing patient outcomes after THA and TKA: is there a difference? Clin Orthop Relat Res. 2010;468(2):542-546. viii Tippett SR, Mang J, Dwyer KA, Lesko J, O’Dell T. Collecting data with palm technology: comparing preoperative expectations and postoperative satisfaction in patients undergoing total knee arthroplasty. J Bone Joint Surg Am. 2010;92:259-67.
ix National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Summary Report for DePuy Synthes ATTUNE CR and ATTUNE PS. NJR Database extract May 6, 2021, page 14 – data derived from general health questions at 6-month post-op follow-up. Licensed for use until May 18, 2022, Available at www.ATTUNEevidence.com (US) and www.provingthepromise.com (EMEA).
x Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), Automated Industry Report System (AIRS), ID No.4155 for DePuy Synthes, ATTUNE CR/ATTUNE Total Knee, (Procedures from 1 September 1999 – 4 May 2021), Accessed 6 May 2021, AOA, Adelaide: 1-17.
xi Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), Automated Industry Report System (AIRS), ID No.4156 for DePuy Synthes, ATTUNE PS/ATTUNE Total Knee, (Procedures from 1 September 1999 – 4 May 2021), Accessed 6 May 2021, AOA, Adelaide: 1-17.
xii National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 17th Annual Report, 2020. Table 3.K7 (a), page 148. Available from: www.njrreports.org.uk.
xiii Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), Automated Industry Report System (AIRS), ID No. 5698 for DePuy Synthes, ATTUNE Total Knee, (Procedures from 1 September 1999 – 7 December 2021), Accessed 9 December 2021.erner J, Kalsekar I, de Moor C, Yoo A, Swank M. Comparative Analysis of Hospital Length of Stay and Discharge Status of Two Contemporary Primary Total Knee Systems. J Knee Surg. 2017. 1(212): 1-10. DOI https://doi.org/10.1055/s-0037-1604442. Premier Perspective™ Database analysis including 38 US hospitals, representing 1,178 primary, unilateral TKAs with the ATTUNE Knee and 5,707 primary, unilateral TKAs with Triathlon™.
vii Bourne R
xiv Ranawat CS, White PB, West S, Ranawat AS. Clinical and Radiographic Results of Attune and PFC Sigma Knee Designs at 2-Year Follow-Up: A Prospective Matched-Pair Analysis. J Arthroplasty 2017;32(2):431-436.
xv W. Tong, B. Smith, et al 2020 ORS paper No 337.
xvi DePuy Synthes TR-000002196 report, Adaptiv, 2018.
xvii DePuy Synthes. Design Verification Study, Forward Dynamics Analysis, DKB Simulation of the Attune MS and Attune CR Designs ,SEA103664945. Adaptive. 2021.
xviii Johal P, Williams A, Wragg P, Hunt D, Gedroyc W. Tibio-femoral movement in the living knee. A study of weight bearing and non-weight bearing knee kinematics using ‘interventional’ MRI. J Biomech. 2005;38(2):269-276.
xix DePuy Synthes. Forward dynamics modeling analysis: multi-patient verification report, SEA103845908. Adaptive. 2021.
xx DePuy Synthes ATTUNE Fix Bearing Knee, IFU 0902-00-902 Rev B.