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Minimally Invasive Lumbar Fusion

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screw

Biomechanical Evaluation (1)

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-9 -6 -3 0 3 6 9 12 15 Rotation in ° Flexion Extension intact Primary Stability intact Primary Stability Coflex rivet Coflex crimped

Biomechanical Evaluation (1)

coflex-F

Test w/o intervertebral support!

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Biomechanical Evaluation (1)

coflex-F

Test w/o intervertebral support!

Segme n tal Tilt x- Axis y-Axis

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Minimally Invasive Lumbar Fusion

The missing piece

Philosophie

… bridging the gap

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Interspinous stabilization with coflex-F is an ideal

adjunct to fusion in cases of degenerative disc disease with or without mild instabilities in the

lumbar spine.

coflex-F allows for segmental stabilization in

combination with interbody fusion cages and is bridging the gap between stand-alone anterior solutions and 360-Fusions using pedicle screw fixation.

coflex-F can be applied in a less-invasive

tissue-sparing procedure significantly reducing iatrogenic damage and promoting shorter rehabilitation for patients.

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Reduced Iatrogenic Trauma

• Less muscle trauma • Less blood loss • Smaller skin incision

• Reduced Surgical Risks

• Excellent safety profile of implant • Protection of neurological structures • Easy and precise application

Adjunct to Interbody Fusion

Concept

• Reduced Cost

• Shorter operating time • Faster patient rehabilitation

• Ease of use

• Simple surgical technique • Easy instrumentation

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0% 50% 100% 150% 200% 250% 0% 50% 100% 150% 200% 250% intact defect cage stand alone Cage / coflex-F Cage / Ped. Screw System

Range of motion and neutral zone normalized with the intact state (100%)

Extension Flexion

ROM NZ

Biomechanical Rationale (2)

coflex-F

Prof. H.-J. Wilke: coflex-F: Biomechanical comparison of two posterior fixation systems. Institute of Orthopaedic Research and Biomechanics, Germany

In combination with cages anteriorly both the coflex-F™ implant and the pedicle screw system reduced the ROM significantly.

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Secure anchorage through screw and sleeve fixation

Good bone anchorage through teeth on inside of wings

U-shape provides large surface area, different sizes allow adjustment of sagittal balance

Pin allows pressfit wing attachment on spinous process

coflex-F Design Features

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Ball and socket

screw/wing interface for optimized load distribution in various wing

angulations

coflex-F Design Features

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Standardhole

1,5 mm 2,1 mm

Ball and Socket

connection with Rivet Ø mm

Ø mm

Patent Pending !

coflex™ versus coflex-F

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1,5 mm

2,1 mm

Patent Pending !

coflex™ versus coflex-F

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Standard Trials

Special Trials

Patent Pending !

coflex™ versus coflex-F

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Overview

Overview

Indication vs.

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The coflex-F system is intended for permanent implantation as an

adjunct to fusion in the region from L1-L5 in up two levels.

The purpose is to achieve

stabilization and to promote fusion in patients with degenerative disc disease

Adjunct to Interbody Fusion

Indications

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The coflex-F system is contraindicated in cases of:

• Degenerative Spondylolisthesis greater than °1 according

to Meyerding classification.

• Any forms of isthmic spondylolisthesis.

• Prior decompressive laminectomy, hemilaminectomy or

significant lamina fenestration which weakens the spinous process.

• Multilevel applications • Cases of L5/S1

Contra-Indications

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The patient is placed in the prone position on a surgical frame avoiding hyperlordosis of the spinal segment(s) to be operated upon.

Patient Positioning

Surgical Technique

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Surgical Strategy

Surgical Technique

Lumbar Interbody Fusion L1 to L5

Anterior Lumbar Interbody Fusion (ALIF)

1. ALIF

2. coflex-F Insertion

Posterior Lumbar Interbody Fusion (PLIF)

1. PLIF

2. coflex-F Insertion

Transforaminal Lumbar Interbody Fusion (TLIF)

1. TLIF

2. coflex-F Insertion

2

1

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Surgical Technique

Intervertebral Implants

Select lordotic cages to ensure maximum cage endplate contact.

Avoid undersizing cages!

Intervertebral space preparation:

Care is taken to remove all nucleus material (which inhibits osteogenesis) prior to cage insertion.

Bone graft should be placed anterior, lateral and medial to the cages to ensure optimal fusion success.

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Facet Joints Status

Surgical Technique

Maintain at least 50% of the medial facet and all of the facet capsules

OK Too

much

Add bone chips (anterior/ lateral and medial to cages) to promote fusion process

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Implant Site Preparation

After the intervertebral device (cage or

machined allograft) has been inserted, trials are utilized to define the appropriate implant size.

Trial instrument is placed to evaluate the proper contact with the spinous processes

avoiding any facet distraction.*

* It is most appropriate to use a coflex-F implant one size smaller than to have distraction of the facets.

Surgical Technique

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Surgical Technique-PLIF

Surgical Technique

Make sure that the oposing facing surfaces of the superior and inferior spinous processes are parallel for

enhanced contact onto the legs of the coflex-F implant

Flat surfaces can be obtained using either osteotomes, rongeurs or

drills.

Maintain adequate spinous process anatomy for optimal fixation

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Surgical Technique

Intervertebral Implants

Mid Portion of facet joint ideal place for U portion

If the laminae are steeply pitched (which can block proper seating of device wings), use a burr or

rongeur to bilaterally fashion the juncture of laminae and base of interspinous process so that the wings seat at the appropriate depth.

The device should seat so that the apex of the „U“ rests at midlevel of the corresponding facet joints of the treated level.

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Implant Insertion

Prior to insertion bending pliers may be necessary to separate the wings.

The coflex-F implant is introduced via impaction utilizing a mallet.

Proper depth is determined if a beaded tip probe can be passed freely leaving 2-3 mm separation from the dura. By deep insertion at the level of the facet joints the coflex-F continues to counteract the majority of posterior column forces.

Surgical Technique

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Once proper placement has been achieved punching pliers are utilized to create holes in the spinous processes for later introduction of the coflex-F screws.

Surgical Technique

Surgical Technique

It is recommended to crimp the implant wings prior to screw insertion. This ensures proper contact to the

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Implant Insertion

Prior to insertion of the coflex-F screws it is recommended to clean the holes using the

coflex-F probe.

Surgical Technique

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Implant Insertion

The coflex-F screws are applied using the screw inserter. A tight fit is required for controlled fixation. Teeth of both wings should be firmly engaged into the cortices of the spinous

processes. Slight additional compression can be obtained manually with wrenches.

Surgical Technique

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Surgical Technique

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Wound Closure

A surgical drain may be placed as per surgeon preference.

The supraspinous ligament is reattached through bone. Skin is closed in the usual manner.

Surgical Technique

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coflex-F™ Marketing Tools

Marketing Tools

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coflex-F™ Marketing Tools - Product Brochure

Table of Content:

ƒ Coflex-F (Introduction + Key Features)

ƒ Surgical Technique ƒ Patient Cases

ƒ Product Information

Marketing Tools

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Coflex-F™ Marketing Tools - Advertisement

The coflex-F™ implant provides significant segmental

stability with all the advantages of an interspinous

implant and is the alternative to pedicle screw fixation as an adjunct to interbody fusion.

•· Reduced iatrogenic trauma •· Faster patient rehabilitation •· Protection of neural structures •· Shorter operating time

•· Secure anchorage through screw and sleeve fixation

Marketing Tools

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coflex-F™ Marketing Tools - Models

coflex-F™ Models are available!

Please contact Customer Service.

Marketing Tools

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DCI™ Workshop – Friday May 30

th

, 2008

Marketing Tools

References

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