Johnson & Johnson MedTech Launches Velys Active Robotic-Assisted System for Planning, Instrumenting Spinal Fusion Procedures

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Johnson & Johnson’s (J&J) Velys active robotic-assisted system (Velys Spine) has officially launched in the United States. Developed by DePuy Synthes, J&J’s orthopedics company, in collaboration with eCential Robotics, Velys is designed for planning and instrumenting spinal fusion procedures across the cervical, thoracolumbar, and sacroiliac spine. The launch comes amid a recent 510(k) clearance from the FDA. According to the company, the device was designed to help surgeons during their most complicated challenges.¹

“We are shaping the next frontier of orthopedic innovation with a relentless focus on digital advancements and excellence in the field of surgical robotics and navigation. Our dedication extends to enhancing patient care through significant strides in spine surgery,” said Aldo Denti, company group chair, DePuy Synthes, in a press release. “This is a major step in growing our Velys portfolio and in our commitment to supporting spine surgeons and their patients with advanced tools.”

J&J stated that the Velys system offers a customizable experience with pathology-specific workflows, including support offered by the Velys adaptive tracking technology and Velys trajectory assistance. It will be implemented along other DePuy Synthes products, such as the TriALTIS spine system and navigation-enabled instruments, Symphony Occipito-Cervico-Thoracic system, Viper Prime system, and the Expedium Verse System.¹

Prior to the FDA clearance, Velys had been cleared for use in over 20 markets, with J&J stating that it has been utilized in over 55,000 procedures to date. In total knee arthroplasty, Velys enables personalized planning to help ensure precise implant placement, alignment, and balance relative to soft tissue. Velys also offers an accubalance graph for personalized balancing throughout the full range of motion, and compatibility with the Sigma HP unicondylar knee system, which the company states has demonstrated improvements to 12-year survivorship.²

“We are committed to continually improving and expanding the capabilities and user experience of our Velys Enabling Technology portfolio,” said Denti, in a press release. “We are excited to add a robotic-assisted offering with our clinically proven implant for UKA which we believe will address some of the key unmet needs in the partial knee replacement segment, including accuracy and simplicity, that other systems on the market do not fully address. Data and analytics will continue to serve as the backbone of our platform, which reveals real-time, actionable insights for surgeons to empower patient-specific operative decisions with the goal to improve outcomes and deliver personalization at scale.”

According to statistics from the American Academy of Orthopedic Surgeons, over 700,000 total knee replacement surgeries are performed in the United States on an annual basis. Further, over 90% of knee replacements are still functioning 15 years after the initial surgery.³

“Today’s landscape of enabling technologies features first-generation robotics systems that may face challenges in adapting to individual surgeon needs,” said Russell Powers, worldwide president, spine, DePuy Synthes, in the press release. “We recognize the urgent need for innovative solutions that offer new ways to engage with enabling technologies, returning control to surgeon’s hands. We believe that the unique features and capabilities of active robotics technology will set a new standard in surgical care for spine patients everywhere.”

References

1. DePuy Synthes Launches its First Active Spine Robotics and Navigation Platform. J&J. August 2, 2024. Accessed August 5, 2024. https://www.jnj.com/media-center/press-releases/depuy-synthes-launches-its-first-active-spine-robotics-and-navigation-platform

2. DePuy Synthes Receives 510(k) FDA Clearance of the VELYS™ Robotic-Assisted Solution for Use in Unicompartmental Knee Arthroplasty Procedures. J&J. June 7, 2024. Accessed August 5, 2024. https://www.jnj.com/media-center/press-releases/depuy-synthes-receives-510k-fda-clearance-of-the-velys-robotic-assisted-solution-for-use-in-unicompartmental-knee-arthroplasty-procedures

3. Total Knee Replacement. OrthoInfo. Accessed August 5, 2024. https://orthoinfo.aaos.org/en/treatment/total-knee-replacement/#:~:text=Total%20knee%20replacement%20is%20one,performed%20annually%20in%20the%20U.S.