West Chester, PA– October 12, 2017 – Today DePuy Synthes* announced the U.S. launch of the new TFNA Augmentation System, the first and only polymethylmethacrylate (PMMA) cement with specific trauma device indications, offered exclusively for use with the TFNA System. The TFNA Augmentation System is used to address the needs of patients with hip fractures and who have poor bone quality.
The TFNA Augmentation System can be used to provide enhanced implant fixation in cases where the potential risk of cut-out is significant. Cut-out is a loss of implant anchorage or stability in the bone, frequently occurring in those with poor bone quality. It causes the femoral neck-shaft angle to collapse, and is a leading clinical complication during hip fracture surgery. Cut-out can also lead to reoperation, which increases risks to the patient and increases costs to the healthcare system. Each year, more than 300,000 hip fractures occur in the U.S.1 These fractures are common in the elderly, especially those with osteoporotic bone. Fractures are expected to increase as the population ages.2 When used together with the TFNA System, the TFNA Augmentation System is designed to help reduce the risk of cut-out and provide enhanced implant fixation.3,4
“The TFNA Augmentation System addresses an important clinical need for patients who undergo hip fracture surgery, especially those who suffer from poor bone quality,” said Charisse Y. Sparks, MD, Franchise Medical Leader Trauma, DePuy Synthes Trauma. “This new system complements the TFNA System and has the potential to improve patient outcomes, reduce costs, and increase patient satisfaction.”
About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies**, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes 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.
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 effectiveness and value of the TFNA Augmentation 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; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; 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 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “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 represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.
©DePuy Synthes 2017. All rights reserved.
1 Agency for Healthcare Research and Quality. National and regional estimates on hospital use for all patients from the HCUP Nationwide Inpatient Sample (NIS). 2013. http://www.ahrq.gov/research/index.html. Accessed 12 October 2015.
2 Cummings SR. Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs and potential effect of postmenopausal estrogen. Clin Orthop Relat Res. 1990;252:163-166
3 DePuy Synthes test data on file, Windchill 0000268245.
4 Hofmann L, Zderic I, Hagen J, Agarwal Y, Scherrer S, Weber A, Altmann M, Windolf M, Gueorguiev B. Biomechanical effect of bone cement augmentation on the fixation strength of TFNA blades and screws. Presented at 22nd Congress of the European Society of Biomechanics. 10-13 July 106. Lyon, France.