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

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Mar 15, 2017, 09:00 ET

SAN DIEGO, March 15, 2017 /PRNewswire/ -- Today, DePuy Synthes*, part of the Johnson & Johnson Family of Companies, announced the 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 San Diego, coinciding with the American Academy of Orthopaedic Surgeons Annual Meeting.

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. It will also extend DePuy Synthes leadership in the category 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. The ATTUNE Knee System can help patients return to their normal activities sooner than anticipated^2-3, while also enabling surgeons and health systems to improve clinical outcomes, reduce costs and increase patient satisfaction.

Implant survivorship data from the 2016 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) confirmed positive early results for the primary ATTUNE Knee.⁴ These data add to other recent registry evidence which has shown that survivorship for the primary ATTUNE Knee compares favorably to other knee systems in its class.⁵ In addition, one-year results from two worldwide studies have shown improved patient reported outcomes measures with the primary ATTUNE Knee compared to other leading knee systems.⁶

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 the ATTUNE 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.

*DePuy Synthes presents the products and service of DePuy Synthes, Inc. and its affiliates

The third-party trademarks used herein are trademarks of their respective owners
DSUS/JRC/0217/2035 March 2017

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

3. 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™.

4. 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

Australian Orthopedic Association National Joint Replacement Registry 2016 Annual Report

Extracted from Table KT9 Cumulative Percent Revision of Primary Total Knee Replacement with Cemented Fixation
Femoral Component	Tibial Component	N Revised	N Total	1 Yr	3 Yrs	5 Yrs	7Yrs	10 Yrs	15 Yrs
Attune CR	Attune	17	3199	0.5 (0.3, 0.9)
Attune PS	Attune	7	1632	0.4 (0.2, 0.9)
Genesis II CR	Genesis II	421	13019	0.9 (0.8, 1.1)	2.4 (2.2, 2.7)	3.1 (2.8, 3.5)	4.0 (3.6, 4.4)	4.3 (3.9, 4.7)	5.6 (4.7, 6.7)
Genesis II PS	Genesis II	518	14812	1.2 (1.1, 1.4)	2.8 (2.6, 3.1)	3.7 (3.4, 4.1)	4.3 (3.9, 4.7)	5.0 (4.5, 5.5)
Journey Oxinium	Journey	220	3032	1.4 (1.0, 1.9)	4.5 (3.8, 5.3)	6.4 (5.5, 7.4)	8.8 (7.6, 10.0)
Nexgen CR Flex	Nexgen	254	16286	0.7 (0.6, 0.8)	1.5 (1.3, 1.7)	2.0 (1.8, 2.3)	2.3 (2.0, 2.6)	2.7 (2.2, 3.2)
Nexgen LPS Flex	Nexgen	838	27014	0.9 (0.8, 1.0)	2.3 (2.1, 2.5)	3.2 (3.0, 3.4)	3.9 (3.6, 4.2)	5.0 (4.7, 5.5)
PFC Sigma CR	PFC Sigma	277	11461	0.8 (0.7, 1.0)	1.9 (1.6, 2.2)	2.4 (2.1, 2.7)	2.9 (2.5, 3.3)	3.4 (3.0, 3.9)
PFC Sigma PS	PFC Sigma	241	7167	1.2 (1.0, 1.5)	2.6 (2.2, 3.0)	3.2 (2.7, 3.6)	3.5 (3.1, 4.0)	4.5 (3.9, 5.3)
Triathlon CR	Triathlon	497	25632	0.8 (0.7, 0.9)	2.1 (1.9, 2.3)	2.6 (2.4, 2.8)	3.0 (2.7, 3.4)	3.8 (3.2, 4.5)
Triathlon PS	Triathlon	185	5886	1.5 (1.2, 1.8)	3.2 (2.7, 3.7)	4.0 (3.4, 4.6)	4.6 (3.9, 5.3)
Vanguard CR	Maxim	133	6778	0.6 (0.4, 0.8)	2.2 (1.8, 2.7)	2.8 (2.4, 3.4)	3.3 (2.7, 4.0)
Vanguard PS	Maxim	166	3500	1.9 (1.5, 2.4)	4.6 (3.9, 5.4)	5.7 (4.9, 6.7)	6.8 (5.7, 8.0)

Table KT22	Cumulative Percent Revision of Primary Total Knee Replacement by Fixation (Primary Diagnosis OA)
Fixation	N Revised	N Total	1 Yr	3 Yrs	5 Yrs	7 Yrs	10 Yrs	15 Yrs
Cemented	8439	258789	1.0 (0.9, 1.0)	2.6 (2.5, 2.6)	3.4 (3.4, 3.5)	4.2 (4.1, 4.3)	5.1 (5.0, 5.3)	7.3 (6.9, 7.7)
Cementless	4612	103903	1.2 (1.1, 1.3)	3.2 (3.1, 3.3)	4.3 (4.2, 4.4)	5.0 (4.9, 5.2)	6.1 (5.9, 6.3)	8.1 (7.7, 8.6)
Hybrid	3964	119262	0.9 (0.9, 1.0)	2.5 (2.4, 2.6)	3.3 (3.2, 3.5)	3.9 (3.8, 4.1)	4.8 (4.7, 5.0)	6.6 (6.2, 7.0)
TOTAL	17015	481954

Note: Excluding cementless Genesis Oxinium and Profix Oxinium femoral prostheses

5. 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%20Report/07950%20NJR%20Annual%20Report%202016%20ONLINE%20REPORT.pdf

6. 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.

SOURCE DePuy Synthes