Orthopaedic patients in Israel are the first in EMEA region to experience the latest advancement in knee robotic assisted surgery
DePuy Synthes,* the Orthopaedics Company of Johnson & Johnson, is pleased to announce that following the approval of the VELYS™ Robotic-Assisted Solution by the Medical Device Division of the Israeli Ministry of Health (AMAR) for commercial use in Israel** the first clinical cases were conducted in Tel Aviv.
The VELYS Robotic-Assisted Solution is part of the broader VELYS Digital Surgery Platform of connected technologies powered by data insights and designed to elevate the orthopaedic experience for patients, surgeons, and their teams across the entire continuum of care, from pre-operative to post-operative.
The VELYS Robotic-Assisted Solution is adaptable technology that is designed around how surgeons plan, execute, and perform surgery for total knee replacement and is indicated for use with the ATTUNE™ Knee System. The VELYS Robotic-Assisted Solution helps address challenges cited with robotic assisted technologies on operational efficiencies and may help to simplify surgeons’ existing workflow.ii
VELYS Robotic-Assisted Solution is a first-of-its-kind operating table mounted solution that utilises advanced planning capabilities, proprietary technology, and a next generation design to help surgeons accurately resect bones that align and position the implant relative to the soft-tissue during total knee replacement without the need for pre-operative imaging. The efficient and compact design integrates into any operating room and does so with a much smaller footprint, at less than half the size of some other robotic-assisted solutions.i,ii
The VELYS Robotic-Assisted Solution provides:
- Valuable Insights: Gap balance data designed to help surgeons visualise and predict joint stability
- Versatile Execution: Intuitive, integrated design intended to give surgeons the control they’re used to while improving daily OR flow
- Verified Performance: Designed to provide accurate, consistent plan execution supporting the ATTUNE Knee in providing better patient outcomesiii,iv,v,vi
CEO of Assuta Medical Center, Mr. Gidi Leshetz, commented, “Bringing this technology to the hospital represents another important step in the realization of Assuta's innovation strategy for spearheading robotics and medical progress in Israel. We believe that the installation of VELYS Robotic-Assisted Solution in a number of Assuta hospitals will help a large population of patients who have been avoiding a knee replacement surgery, as well as surgeons – enabling more precise and effective procedures."
Dr. Amal Khoury, head of Orthopedic Department at Tel Aviv Sourasky Medical Center, added, “VELYS Robotic-Assisted Solution is a simple and intuitive device, which easily integrates into the OR. Learning curve is fast and there is no need to worry about the added operating time – a recent case took us 45 minutes to complete. We are extremely proud to be able to offer better and more accurate medical service to the knee patients of Sourasky Medical Center.”
Dan Danieli, DePuy Synthes Israel Lead, Johnson & Johnson Medical, said, “Orthopaedics is evolving, with increasing patient demand, higher expectations, and an unrelenting focus on driving efficiencies in costs, time, and resources. There is significant opportunity to address unmet needs and we are happy to be able to leverage advanced technology and connected intelligence, in conjunction with our clinically backed portfolio of implants – all to enhance patient outcomes and satisfaction. We look forward to more patients benefiting from the VELYS Robotic-Assisted Solution in hospitals around Israel and the wider EMEA region.”
*DePuy Synthes represents the products and services of Johnson & Johnson Medical Pty Ltd. and its affiliates.
**The approval leveraged the registration documents submitted for the U.S. FDA clearance. This is the first certification for VELYS Robotic-Assisted Solution in EMEA. Israel has a pathway to register the products that is independent of the CE mark. While the VELYS Robotic-Assisted Solution is currently approved for use in Israel, DePuy Synthes is still in the process of submitting its application for CE mark, so the VELYS Robotic-Assisted Solution is not available for sale or commercial use in EMEA countries outside of Israel. Upon CE Approval, the VELYS Robotic-Assisted Solution will become a key solution within our broader VELYS Digital Platform.
- DePuy Synthes, Internal Report 103732371, RIO Technical User Guide, February 24, 2021, Data on File. (As cited in The VELYS™ Robotic-Assisted Solution Versus Mako® - A Comparison of System Compactness)
- DePuy Synthes, Internal Report 103744839, User Experience Evaluation of the VELYS Robotic-Assisted Solution for Total Knee, July 2020, Data on File.
- Doan et al. Resection Accuracy Improved Using A Novel Concept for Robotic-assisted Total Knee Arthroplasty; ORS 2021 Annual Meeting Paper No. 0333.
- Hamilton W, Brenkel I, Barnett S, et al. Comparison of P.F.C. SIGMA to ATTUNE: A Prospective, Multicenter Study. Podium Presentation at the Closed Meeting of the Knee Society, Sept 2018, St Louis, MO, USA. 2018.
- Fisher D, Parkin D. Optimizing the Value of Your Patients’ TKA: How to Leverage Data from Patient Reported Outcomes, Becker’s Hospital Review, webinar recording, Oct. 2019, www.ATTUNEevidence.com/clinical-evidence, last accessed 01-24-22.
- Ranawat CS, White PB, West S, Ranawat AS. Clinical and Radiographic Results of ATTUNE and PFC SIGMA Knee Designs at 2-Year Follow-Up: A Prospective Matched-Pair Analysis. J Arthroplasty 2017; 32:431-6.
Please refer to the Instructions for Use for a complete list of indications, contraindications, warnings and precautions.
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