CARLSBAD, Calif.--(BUSINESS WIRE)--Spinal Elements, a spine technology company, today announced the publication of positive clinical outcomes data with the Luna XD multi-expandable implant system. The retrospective analysis of 69 consecutive patients over a 2-year period demonstrated statistically significant improvement in leg pain, back pain, disability index, and additional patient-reported outcome measures. In addition, statistically significant increases in anterior and posterior disc height, and foraminal height were observed, as were significant reductions of spondylolisthesis (when present), all while increasing overall lumbar lordosis.
“I am very pleased to share in this peer-reviewed publication these results demonstrating the consistency and positive outcomes that are achievable via an MIS TLIF approach,” states Dr. Fessler. “In this application, I have long believed that Orbit discectomy instruments and Luna XD implants are unique and exceptional in their capabilities. This publication now joins an increasing body of work demonstrating the positive outcomes achievable with this combination.”
The Orbit system consists of articulating and rotating discectomy instrumentation that uses a minimal, posterior incision and/or MIS tubular approach to achieve efficient disruption and removal of disc tissue while preparing the endplates for fusion. The novel articulating rotary design allows the instrumentation’s working end to evacuate the full area of the disc necessary for implantation of the Luna XD device.
The Luna XD system allows an ALIF-sized, circular implant to be surgically delivered to the intervertebral space through a posterior, minimally-invasive access point. Once inserted, the Luna XD implant first expands horizontally to cover the disc footprint, creating a stable foundation. Then the implant expands vertically up to 16mm to restore disc height. Furthermore, the device includes up to 12° of lordosis to aid in the restoration of sagittal alignment.
Spinal Elements acquired the Luna XD and Orbit systems in December 2020 along with the assets of the former Benvenue Medical. Luna XD and Orbit have been integrated as the newest technologies within Spinal Elements’ MIS Ultra™ platform of products and procedural solutions. The company achieved its previously announced goal of relaunching the technology by Q2 and continues making significant progress towards a broad re-release in the coming weeks.
Jason Blain, CEO of Spinal Elements, stated, “I have been thrilled with the organization’s execution in the Luna XD and Orbit acquisition and re-launch effort. Even more inspiring has been the customer experiences I have observed as we reach more surgeon customers and patients... the positive reactions are unlike anything I’ve seen. We look forward to the broader release in the coming weeks and months.”
For full peer-reviewed article, please visit: https://doi.org/10.3171/2020.11.SPINE201139
About Spinal Elements
Spinal Elements is a technology-driven company headquartered in Carlsbad, California. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery. The company markets a complete portfolio of advanced spinal implant technologies. For more information, please visit www.spinalelements.com.
Reference:
Woodward, Josha, et al. (2021). Transforaminal Lumbar Interbody Fusion Using a Novel Minimally Invasive Expandable Interbody Cage: Patient-Reported Outcomes and Radiographic Parameters. Journal of Neurosurgery: Spine, pp. 1–7., doi:10.3171/2020.11.spine201139.