PALM BEACH GARDENS, Fla., Jan. 19, 2021 /PRNewswire/ — At this time, The Johnson & Johnson Medical Gadgets Corporations* introduced that DePuy Synthes** has obtained 510(ok) clearance from the U.S. Meals and Drug Administration (FDA) for the VELYS™ Robotic-Assisted Resolution designed to be used with the ATTUNE® Complete Knee System and its cleared indications to be used. It would develop into a part of the broader VELYS Digital Surgical procedure Platform of linked applied sciences.
With a rising and growing old affected person inhabitants, demand for joint alternative surgical procedure is growing. However throughout the trade, information reveals as much as 20% of knee alternative sufferers aren’t glad with the result of their surgical procedure.1,2 Know-how developments that assist surgeons handle ache, perform and alignment may assist facilitate a constructive enchancment in high quality of life for sufferers.3
The VELYS Robotic-Assisted Resolution is a first-of-its-kind desk mounted answer, with an environment friendly design that integrates into any OR. The system adapts to the surgeon’s workflow, and is designed to provide them the management they’re used to and helps them execute correct bony cuts.4 It makes use of superior planning capabilities, proprietary know-how and a next-generation design to assist surgeons to precisely resect bones that align and place the implant relative to the soft-tissue throughout complete knee alternative with out the necessity for pre-operative imaging.
It simplifies knee alternative surgical procedure by offering the next advantages:
- Beneficial Insights: Hole steadiness information to assist surgeons visualize and predict joint stability
- Versatile Execution: Instinctive, built-in design to provide surgeons the management they’re used to whereas optimizing every day OR stream5
- Verified Efficiency: Correct, constant plan execution supporting the ATTUNE Complete Knee in offering higher affected person outcomes4,6,7,8
“I’ve used the VELYS Robotic-Assisted Resolution in a number of of my ATTUNE Knee procedures and have discovered the VELYS Robotic-Assisted Resolution to be correct, quick and environment friendly,” mentioned Dr. Mark Clatworthy,*** orthopaedic surgeon at MercyAscot Hospital in Auckland, New Zealand, who carried out the primary ATTUNE Knee process utilizing the VELYS Robotic-Assisted Resolution. “The machine permits me to guage the bony anatomy and gentle tissue envelope of the knee to plan the optimum implant place after which use the robotic-assisted answer to ship and execute the plan. I’ve discovered my knees to be properly balanced on the finish of the process and my sufferers are doing properly post-operatively.”
The VELYS Robotic-Assisted Resolution works with the ATTUNE Complete Knee, which has been proven to enhance affected person reported outcomes by working in concord with the affected person’s anatomy to ship each stability and movement by proprietary applied sciences.6,7,8,9,10 Collectively, these applied sciences intention to outline a excessive normal for affected person efficiency and elevate the general knee alternative expertise.
“Globally, earlier technology robotics have solely penetrated key orthopaedic segments between 5-10% of the market. A major alternative for mixed robotic and digital surgical procedure know-how exists. Coupled with the ATTUNE Complete Knee, the VELYS Robotic-Assisted Resolution is extremely differentiated and might help enhance scientific outcomes and enhance affected person satisfaction, offering a extra engaging scientific answer to present choices available on the market,” mentioned Aldo Denti, Firm Group Chairman, DePuy Synthes Franchise****. “With the addition of the VELYS Robotic Assisted Resolution to our VELYS Digital Surgical procedure Platform, we’re persevering with our imaginative and prescient to be essentially the most customized and linked orthopaedics firm.”
The VELYS Digital Surgical procedure platform is comprised of linked applied sciences which might be powered by information insights and designed to raise the orthopaedic expertise for sufferers, surgeons, and their groups throughout the whole continuum of care, from pre-operative to post-operative.
The VELYS Robotic-Assisted Resolution was designed from proprietary know-how developed by Orthotaxy, a privately-held developer of software-enabled surgical procedure applied sciences acquired by Johnson & Johnson Medical Gadgets Corporations in 2018.
For extra data on VELYS™ Digital Surgical procedure go to www.VELYSDigitalSurgery.com.
For extra data on the ATTUNE Knee go to www.ATTUNEevidence.com.
About Johnson & Johnson Medical Gadgets Corporations
At Johnson & Johnson Medical Gadgets Corporations, we’re serving to individuals dwell their finest lives. Constructing on greater than a century of experience, we sort out urgent healthcare challenges, and take daring steps that result in new requirements of care whereas bettering individuals’s healthcare experiences. In surgical procedure, orthopaedics, imaginative and prescient and interventional options, we’re serving to to save lots of lives and paving the way in which to a more healthy future for everybody, in every single place.
About DePuy Synthes
DePuy Synthes, a part of the Johnson & Johnson Medical Gadgets Corporations, gives one of the complete orthopaedics portfolios on the earth. DePuy Synthes options, in specialties together with joint reconstruction, trauma, craniomaxillofacial, spinal surgical procedure and sports activities drugs, are designed to advance affected person care whereas delivering scientific and financial worth to well being care programs worldwide. For extra data, go to www.depuysynthes.com.
* Comprising the surgical procedure, orthopaedics, imaginative and prescient and interventional options companies inside Johnson & Johnson’s Medical Gadgets phase.
** DePuy Synthes represents the services of DePuy Synthes, Inc. and its associates.
*** Dr. Mark Clatworthy is a surgeon innovator for DePuy Synthes Joint Reconstruction.
**** Aldo Denti is employed by Johnson & Johnson.
Cautions Regarding Ahead-Trying Statements
This press launch comprises “forward-looking statements” as outlined within the Non-public Securities Litigation Reform Act of 1995 concerning VELYS Robotic-Assisted Resolution. 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 may differ materially from the expectations and projections of DePuy Synthes 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 opponents; manufacturing difficulties and delays, product efficacy or security issues leading to product recollects or regulatory motion, adjustments to relevant legal guidelines and laws, together with international well being care reforms; adjustments in conduct and spending patterns of purchasers of well being care services; and developments towards well being care value containment. An extra checklist and descriptions of those dangers, uncertainties and different elements could be present in Johnson & Johnson’s Annual Report on Kind 10-Ok for the fiscal yr ended December 29, 2019, together with within the sections captioned “Cautionary Word Relating to Ahead-Trying Statements” and “Merchandise 1A. Threat Components,” and within the firm’s most just lately filed Quarterly Report on Kind 10-Q, and the corporate’s subsequent filings with the Securities and Change Fee. Copies of those filings can be found on-line at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Gadgets Corporations nor Johnson & Johnson undertakes to replace any forward-looking assertion on account of new data or future occasions or developments.
© DePuy Synthes 2021. All rights reserved.
Please consult with the directions to be used for a whole checklist of indications, contraindications, warnings and precautions.
1 Bourne, R.B, Chesworth, B.M., et al. Affected person Satisfaction after Complete Knee Arthroplasty: Who’s glad and who isn’t? Scientific Orthopaedics and Associated Analysis. 2010 468:57-63.
2 Baker, P.N., van der Meulen, J.H., et al. The Function of Ache and Perform in Figuring out Affected person Satisfaction After Complete Knee Substitute. Journal of Bone & Joint Surgical procedure. 2007; 89-B:893-900.
3 da Silva RR, Santos AA, de Sampaio Carvalho Junior J, Matos MA. High quality of life after complete knee arthroplasty: systematic evaluation. Rev Bras Ortop. 2014;49(5):520-7.
4 Doan G, Curtis P, Wyss J, Clary C. Resection Accuracy Improved throughout Robotic-Assisted Complete Knee Arthroplasty – a Cadaveric Examine. Inner Report 103720852.
5 Person expertise analysis of the VELYS Robotic-Assisted Resolution for complete knee (July 2020). Inner Report 103744839.
6 Hamilton W, Brenkel I, Barnett S, et al. Comparability of P.F.C. SIGMA to ATTUNE: A Potential, Multicenter Examine. Podium Presentation on the Closed Assembly of the Knee Society, Sept 2018, St Louis, MO, USA. 2018.
7 Fisher D, Parkin D. Optimizing the Worth of Your Sufferers’ TKA: How one can Leverage Information from Affected person Reported Outcomes, Becker’s Hospital Overview, webinar recording, Oct 2019, www.ATTUNEevidence.com/clinical-evidence, final accessed 10-18-19.
8 Ranawat CS, White PB, West S, Ranawat AS. Scientific and Radiographic Outcomes of ATTUNE and PFC SIGMA Knee Designs at 2-Yr Observe-Up: A Potential Matched-Pair Evaluation. J Arthroplasty 2017; 32:431-6.
9 Indelli PF, Pipino G, Johnson P, Graceffa A, Marcucci M. Posterior-stabilized complete knee arthroplasty: a matched pair evaluation of a traditional and its evolutional design. Arthroplasty At this time 2016; 2:193-8.
10 Pfitzner T, Moewis P, Stein P, et al. Modifications of femoral element design in multi-radius complete knee arthroplasty result in increased lateral posterior femoro-tibial translation. Knee Surg Sports activities Traumatol Arthrosc. 2017. doi: 10.1007/s00167-017-4622-7. [Epub ahead of print].
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SOURCE Johnson & Johnson Medical Gadgets Corporations
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