SMART SPINALFUSION™

WHAT ISSMART SPINAL FUSION™?

FIRST-TIME-RIGHT

SMART SPINAL FUSION™

FIRST TIME RIGHT

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WHAT ISFIRSTTIMERIGHT?

Happy patients, pain free with excellent functionality

with the intention to avoid revision surgery

Understanding where spine surgery has its limits has been the strongest driver of our innovation

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non-fusionimplant migration and subsidencesuboptimal spinal alignmentimmunological reaction imaging artefacts

Major issues in spinal surgery

SMART SPINAL IMPLANTS™

3-D PRINTEDCELLULARTITANIUM®

WHYSMART SPINAL IMPLANTS™?

THEY ADD UP TO FIRST-TIME-RIGHT

FIRST-TIME-RIGHT

1. PRIMARY STABILITY

FIRST-TIME-RIGHT

1. PRIMARY STABILITY2. OSTEO ACTIVE SCAFFOLD

FIRST-TIME-RIGHT

1. PRIMARY STABILITY2. OSTEO ACTIVE SCAFFOLD3. SPINAL BALANCE

FIRST-TIME-RIGHT

1. Primary stability

Providing sufficient stability avoiding micro motion and allowing direct bony ingrowth

MACRO ROUGH SURFACE

Shaped for smooth insertion, to adapt to endplate anatomy and allowing sagittal and coronal alignment

ANATOMICAL DESIGN

2. Osteo active scaffold

Micro-structure and nano-surface for natural bone ingrowth

CELLULAR TITANIUM®

Size and shape of the pore do matter

MICRO-STRUCTURE

diamond shape ideal size (~650 µm) 80% porosity maximal cell surface contact area proper space for vessels and bone cells

Chemical and heat treatments increase total surface for cell attachment and potentially add to biological activity

NANO-SURFACE

Close to cancellous bone - possibly avoiding stress shielding and implant subsidence

MODULUS OF ELASTICITY

The osteo active scaffold is misleading the osteoblasts to start the bone healing process and bone maturation.

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3. Spinal balance

Designed to help restore sagittal and coronal alignment

RESPECT FOR ANATOMYOF THE SPINE

PRODUCT PORTFOLIO

3 IMPORTANT CRITERIA FORSMART SPINAL FUSION™

1. PRIMARY STABILITY2. OSTEO ACTIVE SCAFFOLD3. SPINAL BALANCE

FIRST-TIME-RIGHT

AND IT SHOWS ...

Pre-operative X-Ray and MRI

X-Ray Cervical

Direct operative 3 months postoperative

X-Ray EIT CervicalCage, Male 45 yrs

C5-C6, HNP/DDD

Excellent clinical improvement after 3 months, remaining after 1 yr follow up.

Courtesy of dr. Jasper Wolfs and dr. Mark Arts MCH The Hague, Netherlands

1 year postoperative Flexion – Extension X-Rays

X-Ray Cervical

Courtesy of dr. Jasper Wolfs and dr. Mark Arts MCH The Hague, Netherlands

Note bone bridging anterior of the cage

X-Ray Cervical double level

6 months Post-op ROM C5-C6 = 2.0°ROM C6-C7 = 2.9°with FXA dynamic X-Ray analysis

Courtesy of dr. Jasper Wolfs and dr. Mark Arts MCH The Hague, Netherlands

X-Ray Lumbar PLIF

Without cage and rods With cage, without rods Full fixation and correction

Female 76 yr

360 spondylodese L4-L5

9 mm EIT PLIF cage

Correction of sagittal balance

Only short segment fusion

Courtesy of dr. Mark Havinga en dr. Dean Pakvis, OCON Hengelo, Netherlands

X-Ray Lumbar PLIF

Courtesy of dr. Ulrich Quint, St. Marien-Hospital Hamm, Germany

Implant contours clearly visible under x-ray, nice fit with endplates.

Excellent restoration of the coronal and sagittal balance

X-Ray Lumbar TLIF

X-Ray EIT TLIFcage, Female 54 yr

Degenerative scoliosis

L4-L5

EIT TLIF cage to restore lordosis segmental and Cobb angle in AP direction. Only short-term clinical results known, which are very good.

Post-operative improvement lordosis and neutral axis AP

Courtesy of dr. Steven van Gaalen, Diakonessenhuis Utrecht, Netherlands

X-Ray Lumbar PLIF HL

PLIF High Lordotic implant: 26 x 9 mm 14 height and 12° lordosis

Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia

MRI Cervical (with CIF implant)

Central canal and nerve roots can be evaluated

MRI appearance of EIT Cervical Cage at C5C6 with adjusted protocol T2 – spc – tra

Courtesy of dr. Jasper Wolfs, MCH The Hague, Netherlands

MRI Lumbar (with PLIF implant)

Central canal and nerve roots can be evaluated

MRI appearance of EIT PLIF Cage at L5-S1

Courtesy of dr. Steven van Gaalen, Diakonessenhuis Utrecht, Netherlands

MRI Lumbar (with PLIF HL implant)

Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia

Central canal and nerve roots can be evaluated

CT 1 week postoperative AP view

CT 1 week postoperative lateral view

CT 3 months postoperative AP view

CT 3 months postoperative lateral view

CT Cervical

CT scan EIT Cervical Cage, Male 51 yr

C4-C5, C5-C6, HNP/DDD

Neck and arm-pain for several months

Clinical complaints improved immediately after the operation and are currently still resolved

Note densifying of trabecular structure in vertebral body from 3 months on, especially in the upper vertebrae.

Note thin white layers on both sides of the cage, indicating active bone-ingrowth in the EIT Cellular Titanium® structure.

Settings of (wide) window 2800-3200, and level 1000-1250 create optimal imaging to allow assessment of bone ingrowth in a porous titanium implant

Courtesy of Mr. Andrew Miles, St John God of Hope, Murdoch, Perth Australia

CT Lumbar PLIF HL

PLIF High Lordotic implant: 26 x 9 mm 14 height and 12° lordosis

Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia

CT Lumbar TLIF

No image distortion or scattering; implant bone contact well defined, postoperative radiolucent area’s (→) quickly filled up with bone(→).Bone-ingrowth into the cage and trabecular thickening in the direction of the force-transmission.

Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia

Double level TLIF direct postoperative and 6 months postoperative

CT Lumbar TLIF

Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia

Single level TLIF 6 months postoperative

No image distortion or scattering; implant bone contact well defined; nice trabecular pattern in the direction of the force transmission

CT Lumbar bone ingrowth TLIF

TLIF 6 months axial white dens area in porous titanium structureindicating bone ingrowth

TLIF 12 months axial increase in size of white dens area in porous titanium structure

Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia

CT Lumbar bone ingrowth TLIF

Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia

TLIF 6 months lateral white dens area in porous titanium structureindicating bone ingrowth

TLIF 12 months lateral increase in size of white dens area in porous titanium structure

WHAT ARE THE BENEFITS OF FIRST-TIME-RIGHT?

Quick elimination of pain, fast return to normal life and avoidance of re-operation

BETTER FOR PATIENTS

One-time-right without a learning curve and more patient satisfaction

BETTER FOR SURGEONS

Optimal imaging minimizing disturbing artefacts on MRI and CT scans

BETTER FOR CLINICAL EVALUATION

Fast rehabilitation and quick return to normal activities

BETTER FOR SECOND LINE CARE

Effective surgeries, positive press and strong position towards insurers

BETTER FOR HOSPITALS

Cost-effective procedures when lowering number of revision surgery

BETTER FOR INSURERS

Is accepting a failure rate useful

when it is not necessary?

Will you take this next step in

fusion technology?

SMART SPINALFUSION™

FOR PEACE OF SPINE

Thank you for your attention