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DEPUY SYNTHES AND ETHICON TO SHOWCASE INTRA OPERATIVE SOLUTIONS AIMING TO MITIGATE SURGICAL SITE INFECTION DURING EFORT CONGRESS

VIENNA, AT – May 31, 2017. Today, DePuy Synthes and Ethicon*, both businesses of Johnson & Johnson Medical Devices, have announced they are joining forces at the18th European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Congress in Vienna, to showcase a range of knee and hip procedural solutions to support health systems in meeting their Triple Aim goals of reducing costs, enhancing patient outcomes and increasing patient satisfaction by reducing the rate of Surgical Site Infections (SSIs).

SSIs are a major health concernthat canhave a significant impact on orthopaedic patients, with infection decreasing patient quality of life and representing a major clinical and economic burden in knee and hip arthroplasty1, 2.

“We see a tremendous opportunity to help improve orthopaedic patient outcomes through cross-portfolio procedural offerings” said Michelle Brennan, Company Group Chair, Johnson & Johnson Medical Devices EMEA.  “Our range of complementary technologies seek to address the need for standardization and efficiencies in the operating room, while mitigating the threat of surgical site infections which can be an unexpected and traumatic event during a patient’s journey to recovery”.

The businesses are proud to be exhibiting their suite of procedural solutions during the congress, including:

  • From DePuy Synthes; the ATTUNE® Knee System,designed to improve functional outcomes for patients, performance for surgeons, and efficiency for providers;and the CORAIL® PINNACLE® Total Hip System, one of the most widely used and clinically successful constructs in total hip replacement 3-8.
  • From Ethicon; wound closure products including the DERMABOND® PRINEO® Skin Closure System which provides a flexible microbial barrier with 99% protection in vitro for 72 hours against organisms commonly responsible for SSIs9, complimented by Ethicon’s range of Plus Sutures, including the STRATAFIX™ Plus Knotless Tissue Control Device - with Ethicon Plus antibacterial triclosan coating. Plus Sutures have been proven in vitro to inhibit colonization of the suture by bacteria associated withSSIs10—11, 13-14.

Johnson & JohnsonMedical Devices remains committedto the fight against SSIs for patients and healthcare systems alike.  Infection prevention is rooted in the company’s heritage and itsrange of knee and hip procedural solutions affords orthopaedic surgeons a collection of complementary technologies across the entire patient pathway, from exposure to closure.

CORAIL® PINNACLE® Total Hip System
Today the CORAIL PINNACLE construct is one of the most widely used and clinically successful constructs in total hip replacement.3-8 TheCORAIL® hip system has been provided to over 1,800,000 patients since first implantation in 1986, and over the last 15 years, the PINNACLE®Acetabular Cup System has been provided to over 2,300,000 patients.3

Using a proven, robust construct design with a strong supportive evidence base can potentially help reduce revision risk and the associated cost burden.19

ATTUNE® Knee System
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 anticipated,15,16 while also enabling surgeons and health systems to improve clinical outcomes, reduce costs and increase patient satisfaction.17-18

Advanced Wound Closure Technology
With its latest wound closure innovations, STRATAFIX™ Knotless Tissue Control Devices and DERMABOND® PRINEO® System, Ethicon continues to lead the way in wound closure helping to improve efficiencies in the OR, reduce wound closure time and optimize healing for patients20, 21, 22, 23.

The STRATAFIX™ Knotless Tissue Control Devices and DERMABOND® PRINEO® System also offer the benefit of addressing certain risk factors associated with Surgical Site Infections (SSIs), which has never been more important as evidence suggests that the rate of SSIs lies between 1.5% and 20% of all procedures12. The DERMABOND® PRINEO® System provides a flexible microbial barrier with 99% protection in vitro for 72 hours against organisms commonly responsible for SSIs9, while the portfolio of STRATAFIX™ Knotless Tissue Control Devices offers Ethicon Plustriclosan-coated sutures, proven in vitro to inhibit colonization of the suture by bacteria associated withSSIs13,14.

In support of triclosan coated sutures - the Centers for Disease Control and Prevention’s (CDC) updated Guideline for the Prevention of Surgical Site Infection, 2017, now includes a recommendation that health care professionals “consider the use of triclosan-coated sutures for the prevention of SSI.” The guideline appeared in the May 3 edition of JAMA Surgery online .

This recent announcement adds to the growing support from other prestigious organizations, including the World Health Organization and the American College of Surgeons and the Surgical Infection Society , on the positive impact of triclosan-coated sutures in reducing the risk of SSI.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, 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 .

About Ethicon
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Family of Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues, and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com and follow us on Twitter @Ethicon.

* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon, Inc. is the legal manufacturer of STRATAFIX™ and DERMABOND® PRINEO®. All other trademarks are the property of their respective owners.

MEDIA CONTACTS
Jennifer Holden

+44 (0) 7880 513728
jholden2@its.jnj.com

Joanna Collins
+44 (0) 7917 534175
jcollin9@its.jnj.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.

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. Patel H, Khoury H, Girgenti D, Welner S, Yu H (2016) Burden of Surgical Site Infections Associated with Arthroplasty and the Contribution of Staphylococcus aureus. Surg Infect (Larchmt) 17 (1): 78-88
  2. Whitehouse JD, Friedman ND, Kirkland KB, Richardson WJ, Sexton DJ (2002) The impact of surgical-site infections following orthopedic surgery at a community hospital and a university hospital: adverse quality of life, excess length of stay, and extra cost. Infect Control Hosp Epidemiol 23 (4): 183-189
  3. CORAIL PINNACLE Sales Data; 1986-2016; Data on file DePuy Synthes.
  4. Orthopaedic Data Evaluation Panel. ODEP product ratings. Latest ODEP ratings can be found at www.odep.org.uk [Accessed 01/10/2016].
  5. Hallan G, Lie SA, Furnes O, Engesaeter LB, Vollset SE, Havelin L. Medium and long-term performance of 11 516 uncemented primary femoral stems from the Norwegian arthroplasty register. J. Bone Joint Surg. 2007;89-B:1574-1580.
  6. Chatelet J-C. Survivorship in 120 consecutive cases at 12 years. Rev Chir Orthop Reparatrice Appar Mot. 2004;90(7):628-635.
  7. Bedard N, Callaghan J, Stefl M, Williams T, Liu S, Goetz D. Fixation and Wear with Contemporary Acetabular Components and Cross-Linked Polyethylene at 10-Year Follow- Up. Journal of Arthroplasty. 2014; 29: 1961-1969.
  8. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 13th Annual Report, 2016. Table 3.9. Available from www.njrreports.org.uk
  9. Ethicon Inc, 06TR071 [Study Report for in vitro evaluation of microbial barrier properties of DERMABOND™ ProTape ], December 2006, Data on File.
  10. Storch ML, et al. Experimental efficacy study of coated VICRYL plus antibacterial suture in guinea pigs challenged with Staphylococcus aureus. Surg Infect (Larchmt) 2004;5:281–8
  11. Fleck T, et al, Triclosan-coated sutures for the reduction of sternal wound infections: economic considerations, Ann Thorac Surg. 2007; 84: 232–236
  12. Leaper DJ, et al. Surgical site infection - a European perspective of incidence and economic burden. Int Wound J 2004;1:247–73
  13. Ming X, Rothenburger S, Nichols MM. In vivo and invitro antibacterial efficacy of PDS Plus (polidioxanone with triclosan) suture. Surg Infect. 2008;9(4):451-457
  14. Ming X, Rothenburger S, Yang D. In vitro antibacterial efficacy of Monocryl Plus Antibacterial Suture (poligelcaprone 25 with triclosan). Surg Infect. 2007;8(2):201-207
  15. 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
  16. 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™.
  17. Fisher DR & Parkin P. Improving the Value of Primary Total Knee Arthroplasty: the ATTUNE® Knee System. March 2017. Available from  www.ProvingthePromise.com [Accessed May 2017]
  18. 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.
  19. Using a Proven Primary Total Hip Replacement System Could Reduce the Financial Burden Associated with Revision Hip Arthroplasty. January 2017. DePuy Synthes CA#DSEM/JRC/1216/0729
  20. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928/01477447-20110714-35.
  21. Burgess LP, Morin GV, Rand M, Vossoughi J, Hollinger JO. Wound healing. Relationship of wound closing tension to scar width in rats. Arch Otolaryngol Head Neck Surg. 1990;116(7):798-802.
  22. DOF 07CS003 Multi-centre study to show equivalence of DERMABOND PROTAPE to INTRADERMAL SUTURES for skin closure of full thickness surgical incisions associated with breast procedures. Final Report 09 July 2010.
  23. Kannon GA, Garrett AB. Moist wound healing with occlusive dressings. Dermatol Surg. 1995;21:583-590.

 

 

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