PALM BEACH GARDENS, Fla., Jan. 19, 2021 /PRNewswire/ — As we speak, The Johnson & Johnson Medical Gadgets Firms* introduced that DePuy Synthes** has acquired 510(okay) clearance from the U.S. Meals and Drug Administration (FDA) for the VELYS™ Robotic-Assisted Answer designed to be used with the ATTUNE® Complete Knee System and its cleared indications to be used. It would turn out to be a part of the broader VELYS Digital Surgical procedure Platform of linked applied sciences.
With a rising and growing older affected person inhabitants, demand for joint substitute surgical procedure is growing. However throughout the trade, knowledge exhibits as much as 20% of knee substitute sufferers aren’t happy with the result of their surgical procedure.1,2 Expertise developments that assist surgeons deal with ache, operate and alignment may assist facilitate a constructive enchancment in high quality of life for sufferers.3
The VELYS Robotic-Assisted Answer 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 offer them the management they’re used to and helps them execute correct bony cuts.4 It makes use of superior planning capabilities, proprietary expertise and a next-generation design to assist surgeons to precisely resect bones that align and place the implant relative to the soft-tissue throughout whole knee substitute with out the necessity for pre-operative imaging.
It simplifies knee substitute surgical procedure by offering the next advantages:
- Beneficial Insights: Hole stability knowledge to assist surgeons visualize and predict joint stability
- Versatile Execution: Instinctive, built-in design to offer surgeons the management they’re used to whereas optimizing day by day OR circulation5
- 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 Answer in a number of of my ATTUNE Knee procedures and have discovered the VELYS Robotic-Assisted Answer 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 Answer. “The system allows me to guage the bony anatomy and smooth 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 effectively balanced on the finish of the process and my sufferers are doing effectively post-operatively.”
The VELYS Robotic-Assisted Answer 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 means of proprietary applied sciences.6,7,8,9,10 Collectively, these applied sciences goal to outline a excessive normal for affected person efficiency and elevate the general knee substitute expertise.
“Globally, earlier technology robotics have solely penetrated key orthopaedic segments between 5-10% of the market. A big alternative for mixed robotic and digital surgical procedure expertise exists. Coupled with the ATTUNE Complete Knee, the VELYS Robotic-Assisted Answer is very differentiated and can assist enhance scientific outcomes and enhance affected person satisfaction, offering a extra enticing 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 Answer to our VELYS Digital Surgical procedure Platform, we’re persevering with our imaginative and prescient to be essentially the most personalised and linked orthopaedics firm.”
The VELYS Digital Surgical procedure platform is comprised of linked applied sciences which are powered by knowledge insights and designed to raise the orthopaedic expertise for sufferers, surgeons, and their groups throughout all the continuum of care, from pre-operative to post-operative.
The VELYS Robotic-Assisted Answer was designed from proprietary expertise developed by Orthotaxy, a privately-held developer of software-enabled surgical procedure applied sciences acquired by Johnson & Johnson Medical Gadgets Firms 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 Firms
At Johnson & Johnson Medical Gadgets Firms, we’re serving to folks stay 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 enhancing folks’s healthcare experiences. In surgical procedure, orthopaedics, imaginative and prescient and interventional options, we’re serving to to avoid wasting lives and paving the way in which to a more healthy future for everybody, all over the place.
About DePuy Synthes
DePuy Synthes, a part of the Johnson & Johnson Medical Gadgets Firms, supplies one of the vital complete orthopaedics portfolios on the planet. DePuy Synthes options, in specialties together with joint reconstruction, trauma, craniomaxillofacial, spinal surgical procedure and sports activities medication, are designed to advance affected person care whereas delivering scientific and financial value to well being care methods 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-Wanting Statements
This press launch accommodates “forward-looking statements” as outlined within the Non-public Securities Litigation Reform Act of 1995 relating to VELYS Robotic-Assisted Answer. The reader is cautioned to not depend on these forward-looking statements. These statements are primarily based 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 embody, however aren’t restricted to uncertainty of business success; challenges to patents; competitors, together with technological advances, new merchandise and patents attained by rivals; manufacturing difficulties and delays, product efficacy or security considerations leading to product recollects or regulatory motion, adjustments to relevant legal guidelines and rules, together with world well being care reforms; adjustments in habits and spending patterns of purchasers of well being care services; and developments towards well being care value containment. An extra record and descriptions of those dangers, uncertainties and different elements could be present in Johnson & Johnson’s Annual Report on Type 10-Okay for the fiscal 12 months ended December 29, 2019, together with within the sections captioned “Cautionary Observe Concerning Ahead-Wanting Statements” and “Merchandise 1A. Threat Elements,” and within the firm’s most not too long ago filed Quarterly Report on Type 10-Q, and the corporate’s subsequent 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 the Johnson & Johnson Medical Gadgets Firms 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 check with the directions to be used for an entire record of indications, contraindications, warnings and precautions.
1 Bourne, R.B, Chesworth, B.M., et al. Affected person Satisfaction after Complete Knee Arthroplasty: Who’s happy and who will not be? Scientific Orthopaedics and Associated Analysis. 2010 468:57-63.
2 Baker, P.N., van der Meulen, J.H., et al. The Position of Ache and Perform in Figuring out Affected person Satisfaction After Complete Knee Alternative. 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 whole knee arthroplasty: systematic overview. 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 Research. Inside Report 103720852.
5 Consumer expertise analysis of the VELYS Robotic-Assisted Answer for whole knee (July 2020). Inside Report 103744839.
6 Hamilton W, Brenkel I, Barnett S, et al. Comparability of P.F.C. SIGMA to ATTUNE: A Potential, Multicenter Research. 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 you 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 2-12 months 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 whole knee arthroplasty: a matched pair evaluation of a basic and its evolutional design. Arthroplasty As we speak 2016; 2:193-8.
10 Pfitzner T, Moewis P, Stein P, et al. Modifications of femoral element design in multi-radius whole 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 Firms