DePuy Synthes Launches CONCORDE LIFT Expandable Interbody Implant as Part of a New Procedural Solution for Minimally Invasive Spine Surgery (MIS) that Enhances Surgical Efficiency

News provided by

Jul 26, 2018, 08:35 ET

RAYNHAM, Mass., July 26, 2018 /PRNewswire/ -- Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes** is launching the CONCORDE LIFT Expandable Interbody Device in the U.S. The CONCORDE LIFT Implant is designed to treat patients suffering from degenerative disc disease as part of the new offering called UNLEASH MIS TLIF (Transforaminal Lumbar Interbody Fusion) Procedural Solution. The complete system includes a comprehensive set of solutions to help simplify key stages of this surgery by enhancing surgical efficiency.

During spinal fusion surgery, the degenerated disc is removed and the CONCORDE LIFT Expandable Interbody Device is implanted in its place to help restore the disc height between the two vertebrae in the spine.

"I've had the privilege of performing one of the first cases of spinal fusion surgery using the CONCORDE LIFT Implant in the United States and have been very happy with what I have been able to achieve using this device," said John Hall, M.D., Spine and Orthopaedic Trauma Surgeon***. "I believe that being able to access the disc through a small space and then controllably expanding the cage to fill the disc space allowed me to achieve a reliable fusion."

By 2020, it is estimated that half of all spinal fusion procedures will be performed using a minimally invasive approach.¹ While it has a steep learning curve, minimally invasive spine surgery has been associated with reducing complications, blood loss, muscular damage and pain, with a faster recovery for patients compared to conventional open spine surgery.^2,3

This MIS TLIF Procedural Solution was developed by DePuy Synthes Spine to simplify key stages of the MIS TLIF surgery and additionally includes the CONCORDE Clear MIS Discectomy Device and the VIPER PRIME System for percutaneous pedicle screw insertion. Here are the steps involved in the procedure:

The single-use CONCORDE Clear MIS Discectomy Device allows the degenerated disc-clearing process to occur with fewer instrument passes while increasing the amount of disc material removed compared to standard discectomy tools.⁴
The CONCORDE LIFT Expandable Interbody Device is inserted once the disc has been cleared. With this implant, the surgeon can expand the cage to specifically fit the cage to an individual patient's anatomy without being confined to pre-set intervals. The streamlined instrumentation provides tactile feedback during the expansion maneuver and the system offers surgeons the option to back-fill the space with bone graft even after the cage has been fully expanded.
The VIPER PRIME System, aimed at efficiency, combines multiple instruments into one screw inserter tool enabling the surgeon to perform percutaneous pedicle screw insertion in a single instrument pass.

This new offering exemplifies the company's commitment to innovative platforms that are designed to reduce surgical complexity, improve patient outcomes and decrease costs. In an anatomic lab study, this MIS TLIF Solution suggested a potential reduction in instrument passes and showed a reduction in procedure time during disc removal, cage implantation and screw placement compared to a control group of current product offerings****. Based on the early indications of this promising cadaveric study, DePuy Synthes is investing in a health economic study in addition to a clinical study to evaluate the potential benefits of the UNLEASH MIS TLIF Procedural Solution as compared to traditional MIS TLIF procedures.

"This UNLEASH Solution delivers a new offering to help reduce the complexity associated with minimally invasive spine surgery while reducing costs and OR footprint," said Nadav Tomer, Worldwide President, DePuy Synthes Spine. "DePuy Synthes is committed to innovating the tools and technology required to serve more patients globally in a range of care settings by delivering disruptive procedural solutions that improve outcomes supported by real world clinical and economic evidence."

About the Johnson & Johnson Medical Devices Companies
As the world's most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of healthcare. With unparalleled breadth, depth and reach in surgery, orthopaedics and interventional solutions, we're working to profoundly change the way care is delivered. We are in this for life. Learn more about our latest innovations by visiting: https://www.jnjmedicaldevices.com.

About DePuy Synthes
DePuy Synthes 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.

*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
**DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
***Consultant to DePuy Synthes Spine
****Comparing CONCORDE Clear MIS Discectomy Tool to traditional discectomy tools, CONCORDE LIFT Expandable Interbody Device to the CONCORDE Bullet Lumbar Interbody System, and VIPER PRIME System to the VIPER 2 MIS Spine System. Results based on non-clinical study (n=3). Cadaveric test results may not necessarily be indicative of clinical performance.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding CONCORDE LIFT Expandable Interbody Implant as part of a new procedural solution for minimally invasive spine surgery that enhances surgical efficiency. 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 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 DePuy Synthes, Inc., any of 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.

©DePuy Synthes 2018. All rights reserved.
095402-180719

¹ Huang, Tsung-Jen. The State of the Art in Minimally Invasive Spine Surgery. Biomed Res Int. 2017. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5350391/.
² Peng, CW et al. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9.
³ Phan, K et al. Minimally invasive versus open transforaminal lumbar interbody fusion for treatment of degenerative lumbar disease: systematic review and meta analysis. Eur Spine J 24:1017-1030. 2015.
⁴ Lavelle, W et al. An In Vitro Study Examining a Novel Suction Curette Device for Lumbar Discectomy Compared with Standard Manual Discectomy. J Neurosurg Spine 26:454-458. 2017.

SOURCE DePuy Synthes