Novel Horizontally Expandable Minimally Invasive Interbody Fusion

Disclosure of Interest: None Declared
O069
A Novel Horizontally Expandable Minimally Invasive Interbody Fusion Device: 4 Year Clinical
Review of the XYcor Fusion Implant with Radiographic, Biomechanical and Histological
Review
1,*
2
Henry Fabian Larry Cicoretti on behalf of Vertebration, Inc.
1
2
Adult Reconstructive Spine Surgery, The Spine Center of Steamboat Springs, Steamboat Springs,
United States
Preferred presentation method: Oral presentation
Declare any conflict of interest: Yes, I wish to declare the following conflicts.
The authors have the following conflicts: Founding member of Vertebration, Inc., holding company of
the internationally licensed XYcor MIS expandable vertebral body replacement device and patent holder for the
named implant.
Background: To evaluate clinical/biomechanical performance characteristics of a novel, horizontally
expandable, lumbar IBF/VBR device that delivers an standard ALIF cross sectional area/footprint via a 6mm.
annulotomy via a variety of access portals. Results were correlated with radiographic/histologic findings in an
animal model at 26 weeks post implantation. 4 year followup/longitudinal clinical data were reviewed. It is
hypothesized that such an MIS device can deliver clinically optimum results and efficacious clinical
performance comparable to standard open lumbar fusion constructs.
Methods: 49 patients(69 implants) were reviewed over a 4 year year longitudinal study using standard criteria
performance, including all clinical data, patient satisfaction scores, radiographic evaluation/2D CT scanning
reconstruction, return to work data and narcotic utilization. Appropriate informed consent was obtained for this
previously approved US FDA 510(k) VBR device. Biomechanical performance of the device was per the
routine testing requirements of the US FDA/ASTM for VBR/IBF implants and compared to industry accepted
predicate devices. A 26 week, 6 sheep animal study was performed in compliance with all regulations for animal
research and both dynamic/static plain radiographic and 2D CT reconstruction imaging were used. This
radiographic data was correlated with histologic evaluation.
Results: 49 patients underwent implantation of 69 implants from 2008-2010 with a minimum 4 year followup.
There were 4-3 level,19-2 level and 26-1 level fusions with 7 hybrid 2 level constructs allowing direct
comparison to an industry standard PEEK implant at a contiguous level. 67/69 levels fused(97%), patient
satisfaction scores were > 94% and > 90% of patients were discharged in <2 days, all 1 levels in < 1 day. There
were no complications. Multiple patients returned to work in < 8 weeks and all patients returned to work in < 12
weeks. 93% of patients were narcotic free on last followup. All ASTM criteria were met and FEA showed the
implant to have superior performance. Animal study showed a 100% fusion rate with bone bridging in all
quadrants of the device, supported by histologic evaluation at 26 weeks post implantation
Conclusions: The XYcor horizontally expandable lumbar IBF/VBR device is safe and efficacious for clinical
use with superior performance characteristics allowing an ALIF footprint/cross sectional area delivered via a
MIS 6 mm. annulotomy.

Download Report