New MedTech Development Brings First-of-Its-Variety Know-how to Backbone Surgeons, Delivering Superior Visualization and Person-Centric Procedural Management
RAYNHAM, Mass., Oct. 20, 2022 /PRNewswire/ — Right this moment, Johnson & Johnson MedTech* introduced that DePuy Synthes, The Orthopaedics Firm of Johnson & Johnson**, has secured 510(okay) clearance from the U.S. Food and Drug Administration (FDA) for its TELIGEN™ System, an built-in know-how platform that permits minimally invasive surgical transforaminal lumbar interbody fusion (MIS-TLIF) procedures via digital instruments for visualization and entry. The TELIGEN™ System is comprised of a tower that delivers a set of applied sciences, together with: a digital camera management system, a VueLIF-T™ Process Package with a disposable HD digital camera, a TELIGEN™ Clear Discectomy System and patient-based disposable ports. The TELIGEN™ System integrates with the UNLEASH™ bundle of implant options, which is designed to streamline the primary phases in MIS-TLIF.
Low again ache is the main reason for years lived with incapacity globally, with prevalence estimated to be about 7.5% of the inhabitants worldwide, or round 577 million folks.1 For sufferers with degenerative illness, persistent ache, and spinal instability who fail to reply to noninvasive administration, surgical interbody fusion could also be the most suitable choice. Transforaminal lumbar interbody fusion (TLIF) is a typical posterior surgical strategy with favorable fusion charges.2 Open TLIF, nonetheless, can current scientific challenges, together with larger comfortable tissue disruption2, elevated complication danger3-6, slower restoration7,8, and variable long-term outcomes, similar to larger again ache and incapacity.8 MIS-TLIF methods have advanced to cut back issues seen with open TLIF2; nonetheless, they might be related to sure limitations, similar to lack of constant visualization9, steep studying curve9, and occupational hazards to the surgeon.10,11
“The DePuy Synthes TELIGEN™ System with VueLIF-T process has the potential to vary MIS spinal surgical procedure as we all know it,” mentioned Dr. Michael Wang***, Professor of Neurosurgery and Rehab Medication on the College of Miami Medical Heart. “With the TELIGEN™ System, we can have a bigger and clearer area of view – one thing we’ve by no means had earlier than. This expanded visibility will probably be invaluable to enhancing surgical efficiency and finally delivering higher affected person outcomes.”
The TELIGEN™ System delivers a sophisticated visualization expertise and user-centric procedural management. The digitally enabled TELIGEN VUE™ Digicam, positioned on the distal finish of the patient-specific port, eliminates the necessity for a microscope and might present an unobstructed view of the surgical website. It provides hands-free visualization throughout the process, together with a multidirectional and expanded area of view. Moreover, the self-cleaning digital camera contains LED lighting and offers surgeons the flexibility to control picture readability based mostly on their desire. Furthermore, the TELIGEN™ System heads-up show permits for surgeons to keep up ergonomic posture throughout procedures.12 This will assist keep away from vital musculoskeletal ache generally reported by spine surgeons, particularly low again and neck ache.13,14
From an financial lens, relative to open TLIF approaches, MIS-TLIF procedures have been demonstrated to cut back total hospital prices per affected person.15 When in comparison with present MIS applied sciences, the TELIGEN™ System goals to ship efficiencies and value financial savings for hospitals. Based mostly on a small cadaveric research (n=6), the TELIGEN™ System reduces fluoroscopy time by 47% (p=0.003) in comparison with MIS-TLIF procedures carried out utilizing a surgical microscope.16 As well as, the TELIGEN™ System offers a discount in instrument trays and processing prices per surgical procedure for the ten extra trays not required with the TELIGEN™ System.17,18
“Enhancing the MIS spinal surgical procedure expertise for each sufferers and surgeons is a crucial step to addressing unmet wants within the business,” mentioned Russell Powers****, Worldwide President, Backbone, DePuy Synthes. “With our groundbreaking TELIGEN™ Know-how Platform, we’re offering a greater area of view to assist enhance affected person care and improve efficiencies. I’m extremely pleased with this development from our DePuy Synthes crew and the way the VueLIF-T will change MIS spinal procedures.”
DePuy Synthes expects the TELIGEN™ System to be obtainable later this 12 months within the U.S. For extra info on the VueLIF-T process with the TELIGEN™ System and different DePuy Synthes spine specialty merchandise, learn extra right here.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash numerous healthcare experience, purposeful know-how, and a ardour for folks to rework the way forward for medical intervention and empower everybody to dwell their greatest life attainable. For greater than a century, we’ve pushed breakthrough scientific innovation to handle 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 customized. For extra info, go to https://www.jnjmedtech.com.
About DePuy Synthes
DePuy Synthes, The Orthopaedics Firm of Johnson & Johnson, offers one of the complete orthopaedics portfolios on the planet that helps heal and restore motion for the thousands and thousands of sufferers we serve. DePuy Synthes options, in specialties together with joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgical procedure and sports activities drugs, along with the VELYS™ Digital Surgical procedure portfolio, are designed to advance affected person care whereas delivering scientific and financial worth to healthcare programs 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 the complete continuum of care to Hold Folks Shifting at present and tomorrow. For extra info, go to www.depuysynthes.com.
Cautions Regarding Ahead-Wanting Statements
This press launch accommodates “forward-looking statements” as outlined within the Non-public Securities Litigation Reform Act of 1995 relating to the TELIGEN™ 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 recognized or unknown dangers or uncertainties materialize, precise outcomes might range materially from the expectations and projections of DePuy Synthes,Inc. and/or Johnson & Johnson. Dangers and uncertainties embody, however should not restricted to: uncertainty of business success; challenges to patents; competitors, together with technological advances, new merchandise and patents attained by opponents; manufacturing difficulties and delays; product efficacy or security considerations leading to product recollects or regulatory motion; modifications to relevant legal guidelines and laws, together with world well being care reforms; modifications in habits and spending patterns of purchasers of well being care services; and traits towards well being care price containment. An extra listing and descriptions of those dangers, uncertainties and different elements will be present in Johnson & Johnson’s Annual Report on Kind 10-Okay for the fiscal 12 months ended January 2, 2022, together with within the sections captioned “Cautionary Observe Relating to Ahead-Wanting Statements” and “Merchandise 1A. Danger Elements,” and in Johnson & Johnson’s subsequent Quarterly Studies on Kind 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. Neither DePuy Synthes nor Johnson & Johnson undertakes to replace any forward-looking assertion on account of new info or future occasions or developments.
* Comprising the surgical procedure, orthopaedics, imaginative and prescient, and interventional options companies inside Johnson & Johnson’s MedTech section. ** DePuy Synthes represents the services of DePuy Synthes, Inc. and its associates. *** Dr. Wang is a paid advisor for DePuy Synthes and was concerned within the design trials for the TELIGEN™ System. **** Russell Powers is an worker of Medical System Enterprise Companies, Inc.
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