NuVasive will unveil its XLIF lordotic expandable (XLX) interbody system, which just received 510(k) clearance from the US Food and Drug Administration (FDA), at the 25th International Meeting on Advanced Spine Techniques (IMAST) in Los Angeles, which will take place from 11 to 14 July.
NuVasive is a Double Diamond Sponsor of the conference, reflecting its continued support of advancing spine care.
Through controlled lordotic expansion and multifunctional instrumentation, the XLIF anterior column realignment (ACR) technique offers an efficient and minimally disruptive alternative to traditional open procedures.
Leveraging the clinical advantages of the XLIF ACR procedure, the XLX ACR system allows the surgeon to address sagittal alignment from the anterior column while reducing blood loss and hospital stays. Scheduled to launch in July 2018, the XLX implant will be offered in a comprehensive range of lengths and heights with up to 30° of customizable lordosis to address varying patient anatomy.
Leveraging Surgical Intelligence™, the Company’s ecosystem for better surgery, XLX ACR has the ability to improve ACR procedures overall.
The Integrated Global Alignment (iGA®) software can calculate alignment parameters with the preoperative planning tools NuvaLine® and NuvaMap®, and can intraoperatively evaluate correction using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.
“The XLX ACR implant adds the first expandable implant to the portfolio of pathology-specific XLIF interbody options,” said Dr. Ivan Cheng, spine surgeon and Associate Professor of Orthopedic Surgery and, by courtesy, Associate Professor of Neurosurgery at Stanford University.
“We are now better able to achieve correction of alignment and save patients significant morbidity in comparison with traditional approaches of open posterior spinal fusion with osteotomy—procedures which many of our patients may not tolerate or even survive. XLX ACR provides us the ability to maximize lordosis segmentally and customize the optimal amount of overall lordosis based on patient-specific alignment goals using iGA through a minimally disruptive approach.”
The NuVasive XLX Interbody System is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation. It can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
“With the FDA 510(k) clearance of XLX ACR, we broaden our expandable portfolio to the lateral market,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “This clearance highlights our continued investment in innovation and Lateral Single-Position Surgery to transform clinical outcomes by developing and evolving spine’s leading solutions and systems to give surgeons the tools they need to best serve their patients.”
The XLX ACR implant will join the existing expandable interbody portfolio of TLX™ and MLX® as NuVasive’s first lateral expandable. TLX and MLX provide customizable correction with streamlined instrumentation from a TLIF approach.
During IMAST 2018, NuVasive is also showcasing LessRay® within its spine solutions portfolio, a foundational technology within Surgical Intelligence. LessRay offers the surgeon and hospital system the opportunity to use significantly reduced radiation imaging in the operating room, while providing unique Image Stitching for surgeons to quickly stitch together fluoroscopic images of any spine segment.
Source: Company Press Release