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DePuy Synthes Unveils CONCORDE LIFT Expandable Interbody Implant as Part of the Company’s Procedural Solution for Minimally Invasive Spine Surgery (MIS), Designed to Enhance Surgical Efficiency


19 September, Barcelona, SPAIN – DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies** today unveiled the CONCORDE LIFT Expandable Interbody Device to European Surgeons at the EUROSPINE 2018 Meeting, taking place in Barcelona, Spain. The CONCORDE LIFT Implant is designed to treat patients suffering from degenerative disc disease by restoring disc height between vertebrae and completes the Company's UNLEASH MIS TLIF (Transforaminal Lumbar Interbody Fusion) Procedural Solution.

MIS is the fastest growing category in spinal fusion surgery and it is estimated that by 2020, half of all spinal fusion procedures will be performed using a minimally invasive approach.1 MIS TLIF has been associated with lower surgical complications, blood loss, muscular damage and pain, with a faster recovery for patients compared to conventional open spine surgery, yet it is associated with a steep learning curve.2,3

This UNLEASH MIS TLIF Procedural Solution was developed by DePuy Synthes Spine to streamline the 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:

  • In an anatomic lab study of transforaminal discectomies, surgeons required fewer instrument passes and removed more disc material when using the single-use CONCORDE Clear MIS Discectomy Device compared to standard discectomy tools.4
  • The CONCORDE LIFT Expandable Interbody Device is inserted once the disc has been cleared. With the reduced insertion size, the surgeon can easily insert and then expand the cage to specifically fit an individual patient's anatomy without being confined to pre-set intervals. The streamlined instrumentation, suitable for surgeries with limited intervertebral space, 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.


Minimally Invasive Spine surgery has a lot of immediate and short-term advantages for patients, said Dr Parajon***, Head of Spine, Neurosurgical department, Hospital University Ramòn y Cajal, Madrid; and Head of Neurosurgery, Hospital La Milagrosa. “I anticipate that the now complete UNLEASH procedural solution will bring great benefit to surgeons and the entire hospital team.”

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, the MIS TLIF Solution was shown to reduce the total number of instrument passes by 56% (p=0.086) and showed a reduction in procedure time during disc removal, cage implantation and screw placement by 23% (p=.299) compared to a control group of current product offerings. 5 Based on the early indications of this promising bench top study, DePuy Synthes is investing in a health economics 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.

“With the forthcoming introduction of CONCORDE LIFT, we are delighted to be able to offer the complete UNLEASH Procedural Solution to our customers in the EMEA region,” said Jordy Winters, DePuy Synthes Spine Lead EMEA. “This solution provides us with the technology to serve the needs of our customers by reducing the complexities associated with minimally invasive spine surgery.”


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 .


Notes to editors
The CONCORDE LIFT Expandable Interbody Device is currently being introduced to health care professionals in the Europe, Middle East and Africa (EMEA) region during educational and industry events. Commercial availability of this implant is expected later this year.
*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 Johnson & Johnson's Medical Devices segment.
***Dr Parajon is a paid consultant to DePuy Synthes Spine
This publication is not intended for distribution in the USA The third-party trademarks used herein are the trademarks of their respective owners.

©Johnson & Johnson Medical Limited. 2018. All rights reserved.

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#39;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.

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.
5 DePuy Synthes (2018). Comparative ethnographic study of the UNLEASH MIS TLIF solution in a cadaveric lab. (White Paper). 089812-180406. Cadaveric test results may not necessarily be indicative of clinical performance.


 

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