[April 16, 2018] |
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Two Data Presentations Highlight the Unique Potential of Spineology's Duo™ Implant
Spineology Inc., an innovator in anatomy-conserving spine surgery, is
excited to announce that two laboratory studies relating to the
Spineology Duo™ Lumbar Interbody Fusion System were presented at the
recent annual meeting of the International Society for the Advancement
of Spine Surgery (ISASS) in Toronto, Canada.
This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180416005506/en/
Spineology Duo (Photo: Business Wire)
The Duo implant is the first to combine PEEK, titanium, and graft
containment mesh elements. The unique hybrid design includes lateral
PEEK supports integrated with an expandable porous mesh that serves to
contain bone graft. The Duo implant, filled with bone graft after it is
placed in the disc space, provides a large, endplate-conforming graft
pack up to 30mm in width, to help maintain spinal alignment and support
fusion. Due to the unique design of the implant, the Duo System requires
minimal retraction for placement of the implant which may reduce direct
and indirect injury to the neural elements and potentially decrease the
postoperative complications commonly associated with the lateral
decubitus transpsoas approach.
Pierce Nunley, M.D., Director of The Spine Institute of Louisiana and
Lisa Ferrara, Ph.D., President of OrthoKinetic Technologies LLC,
co-authored a study titled "Size Matters: A Novel Interbody Fusion Cage
Design Increases Contact Area for Bone Exchange and Graft
Incorporation." A unique test methodology using pressure-sensitive
contact film demonstrates that the Duo device design facilitates
load-sharing contact between bone graft and endplates to support graft
incorporation during fusion healing. Pressure profiles were generated
during testing for the Duo implants and for monolithic PEEK interbody
cages (Spineology Rampart™ L). The results showed that the expandable
porous mesh of the Duo implant allows for direct contact between bone
graft and the viscoelastic vertebral endplates, improving the endplate
and graft interface mechanics.
Barbara Boyan, Ph.D., Dean of Engineering at Virginia Commonwealth
University, presented the results of an in vitro cell culture model used
to assess whether the Duo implant's polyethylene terephthalate (PET)
mesh would have an impact on migration of osteoprogenitor cells from
vertebral endplates onto bone graft in interbody fusion, and to assess
the biological response of these cells to the bone graft. The study,
titled "Effect of PET Mesh on Mesenchymal Stem Cell Response to Bone
Autograft", indicated that the presence of the porous mesh does not
negatively impact the ability of osteoblast lineage cells to attach to
bone particles, nor does it impede the cells' ability to proliferate or
differentiate along an osteoblastic pathway.
"The graft containment mesh is a key component of the Duo implant
design," said John Booth, CEO, Spineology Inc. "Not only does it allow
for the implant to be placed with minimal retraction and expand in width
up to 30mm once filled in situ, it also provides improved graft loading
properties compared to traditional monolithic PEEK cages and has a
positive impact on osteoprogenitor cell activity, as demonstrated by the
studies presented at ISASS."
Spineology is currently conducting a prospective post-market lateral
interbody fusion study with the Duo System. The primary study objectives
are to gather data related to the new on-set of thigh symptoms, quality
of life measures, and fusion outcomes. The company believes the minimal
amount of retraction required to place the Duo implant will have a
positive impact on post-operative thigh symptoms.
About Spineology Inc. Spineology Inc. provides innovative,
anatomy-conserving spinal technologies for surgeons and their patients.
Spineology surgical techniques conserve spinal bone, ligament and muscle
tissue. Spineology is committed to increasing procedural efficiency,
reducing surgical morbidity and accelerating patient recovery. Learn
more at spineology.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180416005506/en/
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