Post on 11-Sep-2020
transcript
CRANIAL SURGERY SOLUTIONS
MATRIX NEUROTM PREFORMED MESH
INTRODUCTION
DSEM/CMF/0617/0169
Contents
• Current mesh portfolio
• Clinical Need
• Product Description
• Shape Development
• Features & Benefits
• Product Positioning
• Competition
DSEM/CMF/0617/0169
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Current MatrixNEURO contourable meshes
Available in a variety of shapes and sizes
Color coded based on strength characteristic
– Malleable (silver) and Rigid (blue) Mesh:
Mesh thickness = 0.4 mm
– Extra Rigid Mesh (rose):
Mesh thickness = 0.6 mm
– Reconstruction Mesh (gold):
Mesh thickness = 0.6 mm
DSEM/CMF/0617/0169Confidential – For Internal Use Only
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Clinical Need
Clinical Needs
• Simple, ready to use solution for medium to large defects
• Precontoured mesh to reduce the need for prebending
• Minimal preoperative planning
• Can be used for primary reconstruction
• Provides balance between rigidity, contourability and profile
Indication Statement
Indications: For use in craniotomies, cranial trauma repair and
reconstruction.
Contraindication: Use in areas with active or latent infection or
insufficient quantity or quality of bone.
DSEM/CMF/0617/0169Confidential – For Internal Use Only
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Product positioning
Durable, Low Profile,
Conformable
Cli
nic
al
Va
lue
of
Clo
sure
in
te
rms
of
pro
du
ct p
rici
ng
Low
Price
Premium
Price
Patient Specific Implants
Reconstruction
Mesh
Mesh
Ease of Use, OR Efficiency, Customizable
DSEM/CMF/0617/0169Confidential – For Internal Use Only
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Average skull contours from analysis of 80
clinical CT scans1
Defect shapes and locations based on an in-
house clinical cranial defects database2
Scientifically derived3 contours intended to
reduce bending and procedure time
Preformed mesh: Product Description
An off-shelf solution for the treatment of cranial defects
intended to reduce bending and procedure time.
1. Kamer, Lukas, MD, DDS, Noser Hansrudi, PhD, Hammer, Beat, MD, DDS; Anatomical Background for the
Development of Preformed Cranioplasty Implants; The Journal of Craniofacial Surgery, 2013:264-268
2. Data on file.
3. Compared to MatrixNEURO Reconstruction Mesh – data on file.
Universal
FrontalFronto-Temporo-Parietal,
Right & Left
Temporal,
Right & Left
DSEM/CMF/0617/0169Confidential – For Internal Use Only
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Text
• 6 implant portfolio
• Basic material, mesh pattern and rigidity equal to MatrixNEURO Reconstruction Mesh
Product Description
Compatible with MatrixNEURO screws
DSEM/CMF/0617/0169Confidential – For Internal Use Only
Universal Frontal2x Fronto-Temporo-Parietal
(Right & Left)
2xTemporal
(Right & Left)
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The Temporal implant is designed for reconstructions of Temporal defects. The
reconstruction can be combined with standard bone flap fixation following Temporal-
Parietal procedures.
Article
Number
Description
04.503.151S MatrixNEURO Preformed Temporal
Mesh Plate, left, 99 x 66 mm, thickness
0.6 mm, contourable, for
Reconstruction, Pure Titanium, sterile
04.503.152S MatrixNEURO Preformed Temporal
Mesh Plate, right, 99 x 66 mm,
thickness 0.6 mm, contourable, for
Reconstruction, Pure Titanium, sterile
Temporal Implant
DSEM/CMF/0617/0169Confidential – For Internal Use Only
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The FTP implant is designed for reconstruction of large defects in the Fronto-Temporo-
Parietal region.
Article
Number
Description
04.503.155S MatrixNEURO Preformed FTP Mesh
Plate, left, 151 x 125 mm, thickness 0.6
mm, contourable, for Reconstruction,
Pure Titanium, sterile
04.503.156S MatrixNEURO Preformed FTP Mesh
Plate, right, 151 x 125 mm, thickness
0.6 mm, contourable, for
Reconstruction, Pure Titanium, sterile
FTP Implant
DSEM/CMF/0617/0169Confidential – For Internal Use Only
151 mm
125 m
m
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The Frontal implant is designed for reconstructions of the Frontal bone without
involvement of the superior orbital rim.
Article
Number
Description
04.503.157S MatrixNEURO Preformed Frontal Mesh
Plate, 109 x 78 mm, thickness 0.6 mm,
contourable, for Reconstruction, Pure
Titanium, sterile
Frontal Implant
DSEM/CMF/0617/0169Confidential – For Internal Use Only
109 mm
78
mm
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The Universal implant is a dome shaped, circular mesh which can be used for any cranial
defect. The shape and curvature of the mesh is best suited for defects of the Parietal and
Occipital regions.
Article
Number
Description
04.503.158S MatrixNEURO Preformed Universal
Mesh Plate, Ø 109 mm, thickness 0.6
mm, contourable, for Reconstruction,
Pure Titanium, sterile
Universal Implant
DSEM/CMF/0617/0169Confidential – For Internal Use Only
Ø 109 mm
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Preformed Mesh (sterile only) Instruments/Cases
04.503.151S Temporal, L 03.503.602 Bender*
04.503.152S Temporal, R 03.503.605 Mesh cutter*
04.503.155S FTP, L 61.503.230 Instrument tray*
04.503.156S FTP, R
04.503.157S Frontal
04.503.158S Universal
*Previously launched with MatrixNEURO Reconstruction Mesh
List of Products
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1. CT scans of healthy skulls analyzed 2. Statistical analysis shows regions of
high variability
3. 3D shape is complete
Implant Development – Shape approximating the
anatomy
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1. CT scans of
skulls with
defect analyzed
2. Defect size
and location
identified
3. Average defect region and occurrence is
identified*
Implant Development – Defect Location
* Data on file at DepuySynthes
DSEM/CMF/0617/0169Confidential – For Internal Use Only
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Shape, size and defect location are
combined to generate implant design*
Implant Development – Implant Design
* Data on file at DepuySynthes
DSEM/CMF/0617/0169Confidential – For Internal Use Only
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Features Benefits
Availability of implants for repairing
medium/large defects
Intended to reduce procedure time
No patient CT and minimal preoperative
planning required
Provides balance between rigidity and
contourability
Diminishes palpability hence preserves
patient cosmesis
Variety of anatomic shapes based on
clinical CT data
Minimized in situ bending
Hourglass mesh pattern with wider bar
section
Low 0.6 mm mesh and screw profile
Low investment cost and short learning
curveCompatible with MatrixNEURO screws
Features and Benefits
Immediately available and ready to use
DSEM/CMF/0617/0169Confidential – For Internal Use Only
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Product positioning
Durable, Low Profile,
Conformable
Cli
nic
al
Va
lue
of
Clo
sure
in
te
rms
of
pro
du
ct p
rici
ng
Low
Price
Premium
Price Patient Specific
Implants
Preformed
Mesh
Mesh
Ease of Use, OR Efficiency, Customizable
DSEM/CMF/0617/0169Confidential – For Internal Use Only
Reconstruction
mesh
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Competition
Osteomed
OsteoForm Mesh
Biomet
CranioCurve
KLS Martin
Standard Approach Mesh
General dome shapes, non-
specific anatomic regions
Various rigidities and sizes
available
Compatible with OsteoMed’sAutoDrive screws
5 preformed mesh
2x Parietal Small (pictured)
2x Parietal Large
1x Occipital
0.6mm grade II titanium
Compatible with Biomet’s 1.5 Neuro system
11 preformed mesh with
templates
Created using a compilation of
CT scans
0.6 mm thick titanium
Compatible with KLS Martin 1.5
mm Neuro screws
DSEM/CMF/0617/0169Confidential – For Internal Use Only