DePuy Synthes Launches Innovative Nailing System Aimed at Improving Treatment of Femoral Shaft Fractures in the U.S.

New system is designed to enhance anatomic fit and offer surgeons more options to improve patient outcomes

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Jun 07, 2018, 11:42 ET

WEST CHESTER, Pa., June 7, 2018 /PRNewswire/ -- DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announces the U.S. launch of its Femoral Recon Nail System, a nailing system that provides new options for the surgical treatment of a wide variety of long thigh bone fractures. This new system builds on the company's comprehensive trauma portfolio of innovative solutions designed to improve outcomes for patients with hip and femur fractures.

The overall annual number of femoral shaft fractures in the U.S. is estimated at approximately 90,000.¹ The DePuy Synthes Femoral Recon Nail System is a fixation system that utilizes an intramedullary nail to repair femoral shaft fractures. The system provides a surgeon with a state of the art nailing system that is designed to provide stability and allow patients to move soon after surgery while optimizing patient outcomes.

The Femoral Recon Nail System offers surgical entry point and locking options to accommodate varying preferences, and enables surgeons to treat a broad range of complex fractures. The system also features radiolucent insertion handles that aim to reduce surgical complexity, facilitate intraoperative and X-ray visualization, and assist with guide wire placement.

"I believe the DePuy Synthes Femoral Recon Nail System offers the most streamlined insertion instruments on the market," said Pete Nowotarski M.D., Professor Orthopaedic Surgery, University of Tennessee College of Medicine, Chattanooga & Orthopaedic Trauma Director, Erlanger Health Systems***. "This system, coupled with the most advanced design features in both the piriformis fossa and greater trochanter entry points, offers greater versatility in treating complex femur fractures."

In addition, the DePuy Synthes system is also designed to address a potential operative complication called distal cortical impingement, which is often the result of the curve of the patient's femoral anatomy being greater than the curve of the nail.² The Femoral Recon Nail System addresses this issue as it is specifically designed to enhance anatomical fit³ by reducing the rate of nail curvature to more closely match the patient's anatomy that may also further improve the patient's experience.

"DePuy Synthes has a long history of innovation in the hip and femur fracture repair market with a comprehensive portfolio of implants that address a variety of patient needs," said I.V. Hall, Global Platform Leader, DePuy Synthes Trauma. "This launch allows DePuy Synthes to offer the most comprehensive, best-in-class portfolio for hip and femur fractures as we continue to advance the standard of care for patients and improve the surgeon experience."

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, and interventional solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

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.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within the Johnson & Johnson's Medical Devices segment.
***Consultant to DePuy Synthes Trauma

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 Femoral Recon Nail 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, any of the other Johnson & Johnson Medical Devices 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 December 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company'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 the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

¹ Ng AC, Drake MT, Clarke BL, Sems SA, Atkinson EJ, Achenbach SJ, Melton LJ 3rd. Trends in subtrochanteric, diaphyseal, and distal femur fractures, 1984-2007. Osteoporos Int. 2012;23(6):1721-6.
² Roberts JW, Libet LA, Wolinsky PR. Who is in danger? Impingement and penetration of the anterior cortex of the distal femur during intramedullary nailing of proximal femur fractures: preoperatively measurable risk factors. J Trauma Acute Care Surg. 2012;73(1): 249-254.
³ DePuy Synthes Trauma. Data on file. Analysis - Anatomical Study. #0000271671, 2017