DePuy Synthes Receives FDA Clearance for the TriALTIS™ Spine System and Navigation Enabled Instruments

Newest development in Backbone portfolio delivers subsequent era thoracolumbar implant system designed for seamless integration with enabling expertise

RAYNHAM, Mass. – October 9, 2023 – At the moment, Johnson & Johnson MedTech* introduced that DePuy Synthes, The Orthopaedics Firm of Johnson & Johnson**, has secured 510(okay) clearances from the U.S. Food and Drug Administration (FDA) for the TriALTIS™ Backbone System and for TriALTIS™ Navigation Enabled Devices.

The TriALTIS™ Backbone System is a subsequent era posterior thoracolumbar pedicle screw system that provides a complete implant portfolio and superior instrumentation designed for integration with enabling expertise.
TriALTIS™ Navigation Enabled Devices embrace drills, faucets and screwdrivers that may be operated manually or below energy for navigated and non-navigated use.

Combining a brand new portfolio of implants with a digital ecosystem, the TriALTIS™ Backbone System goals to deal with unmet medical wants and assist surgeons obtain extra constant outcomes in treating complicated spine situations, inclusive of degenerative, tumor, trauma and deformity pathologies.

Spinal deformity is a prevalent illness with some research suggesting roughly 32% of adults and as excessive as 68% of adults over the age of 65 are affected.^1-4 Age associated components, heterogenous anatomies and complicated affected person situations make spinal deformity procedures difficult. Because the inhabitants ages, spine surgeons are seeing an growing variety of instances with all kinds of degenerative spinal modifications that require instrumented spinal fusion.⁵ Surgical therapies of sufferers with grownup spinal deformity have been proven to enhance affected person outcomes, and considerably enhance affected person ache, health-related high quality of life, and total remedy satisfaction.⁶

“In relation to treating complicated spinal pathologies, every affected person is totally different, and every case requires its personal distinctive remedy selections,” stated Daniel Sciubba, MD, MBA, Chair & Professor of Neurosurgery at Northwell Health/Hofstra.*** “The TriALTIS™ Backbone System affords a complete implant portfolio that enhances totally different anatomies and procedures and can assist to streamline surgical workflows and allow intraoperative flexibility – all with the potential to enhance medical experiences.”

Constructed on a legacy of dependable thoracolumbar options and experience, the TriALTIS™ Backbone System was developed with a hyper deal with efficiency and a constant person expertise. The inclusive and forward-looking design philosophy of the TriALTIS™ Backbone System affords clean integration with cement augmentation, energy, navigation and robotic-assisted options.

“The TriALTIS™ Backbone System can be our premier pedicle screw platform designed to work seamlessly throughout our total DePuy Synthes portfolio of enabling expertise options,” stated Russell Powers****, Worldwide President, Backbone, DePuy Synthes. “Johnson & Johnson MedTech is proud to ship this thrilling innovation that may assist facilitate the surgical remedy of spinal degeneration and deformity with the purpose to enhance fixation, drive higher affected person outcomes and doubtlessly cut back the medical and financial burden related to the present customary of care. DePuy Synthes has been a pacesetter within the complicated spine house for over 35 years, and the launch of the TriALTIS™ Backbone System will mark a crucial milestone in the direction of our imaginative and prescient to proceed this legacy lengthy into the long run.”

DePuy Synthes expects the TriALTIS™ Backbone System to be accessible within the U.S. in 2024. For extra details about DePuy Synthes Backbone specialty merchandise, learn extra right here.

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash numerous healthcare experience, purposeful expertise, and a ardour for folks to remodel the way forward for medical intervention and empower everybody to reside their finest life potential. For greater than a century, now we have pushed breakthrough scientific innovation to deal with unmet wants and reimagine well being. In surgical procedure, orthopaedics, imaginative and prescient, and interventional options, we proceed to assist save lives and create a future the place healthcare options are smarter, much less invasive, and extra personalised. For extra data, go to https://thenext.jnjmedtech.com/

About DePuy Synthes

DePuy Synthes, The Orthopaedics Firm of Johnson & Johnson, offers one of the crucial complete orthopaedics portfolios on the earth that helps heal and restore motion for the hundreds of thousands of sufferers we serve. DePuy Synthes options, in specialties together with joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgical procedure and sports activities medication, along with the VELYS™ Digital Surgical procedure portfolio, are designed to advance affected person care whereas delivering medical and financial worth to healthcare techniques worldwide. Constructing on our proud product innovation and legacy of business firsts, we’re reimagining the orthopaedic panorama with new developments in medical applied sciences and digital surgical procedure throughout all the continuum of care to Hold Individuals Transferring at present and tomorrow. For extra data, go to www.depuysynthes.com.

Cautions Regarding Ahead-Wanting Statements

This press launch comprises “forward-looking statements” as outlined within the Personal Securities Litigation Reform Act of 1995 concerning the TriALTIS™ Backbone System. The reader is cautioned to not depend on these forward-looking statements. These statements are based mostly on present expectations of future occasions. If underlying assumptions show inaccurate or identified or unknown dangers or uncertainties materialize, precise outcomes might range materially from the expectations and projections of DePuy Synthes, Inc., Medical System Enterprise Providers, Inc., and/or Johnson & Johnson. Dangers and uncertainties embrace, however are usually not restricted to: uncertainty of economic success; challenges to patents; competitors, together with technological advances, new merchandise and patents attained by rivals; manufacturing difficulties and delays; product efficacy or security issues leading to product recollects or regulatory motion; modifications to relevant legal guidelines and laws, together with world well being care reforms; modifications in conduct and spending patterns of purchasers of well being care services; and tendencies towards well being care price containment. An additional record and descriptions of those dangers, uncertainties and different components could be present in Johnson & Johnson’s Annual Report on Type 10-Ok for the fiscal yr ended January 1, 2023, together with within the sections captioned “Cautionary Word Relating to Ahead-Wanting Statements” and “Merchandise 1A. Danger Components,” and in Johnson & Johnson’s subsequent Quarterly Reviews on Type 10-Q and different filings with the Securities and Trade Fee. Copies of those filings can be found on-line at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of DePuy Synthes, Inc., Medical System Enterprise Providers, Inc., nor Johnson & Johnson undertakes to replace any forward-looking assertion on account of new data or future occasions or developments.

* Comprising the surgical procedure, orthopaedics, imaginative and prescient, and interventional options companies inside Johnson & Johnson’s MedTech phase.
** DePuy Synthes represents the services of DePuy Synthes, Inc. and its associates.
*** Daniel Sciubba, MD, MBA is a paid advisor for DePuy Synthes and was concerned within the design trials for the TriALTIS™ System.
**** Russell Powers is an worker of Medical System Enterprise Providers, Inc.

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Parenteau C, Lau E, Campbell I, et al. Prevalence of spine degermation analysis by kind, age, gender, and weight problems utilizing Medicare information. Scientific Reviews. 2021, 11:5389. DOI.
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Zygourakis C, Liu C, Keefe M et al. Evaluation of Nationwide Charges, Price, and Sources of Price Variation in Grownup Spinal Deformity. Neurosurgery. 2018. DOI: 10.1093/neuros/nyx218.
Martin-Fernandez M., Lopez-Herradon, Pinera A, et al. Potential dangers of utilizing cement-augmented screws for spinal fusion in sufferers with low bone high quality. The Backbone Journal. 2017, 1192-119. DOI
Stephens B, Khan I, Chotai S, et al. Drivers of Price in Grownup Thoracolumbar Backbone Deformity Surgical procedure. World Neurosurgery. 2018. 118:e206-e221. DOI