CRANIAL SURGERY SOLUTIONS...CRANIAL SURGERY SOLUTIONS MATRIX NEURO TM PREFORMED MESH INTRODUCTION...

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):


– Reconstruction Mesh (gold):


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.


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Product positioning

Durable, Low Profile,

Conformable

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Price

Premium

Price

Patient Specific Implants

Reconstruction

Mesh

Mesh

Ease of Use, OR Efficiency, Customizable


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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


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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


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


Temporal Implant


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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


FTP Implant


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


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


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


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Shape, size and defect location are

combined to generate implant design*

Implant Development – Implant Design

* Data on file at DepuySynthes


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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


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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


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


CRANIAL SURGERY SOLUTIONS...CRANIAL SURGERY SOLUTIONS MATRIX NEURO TM PREFORMED MESH INTRODUCTION...

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