InFUSE

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InFUSE Bone Graft /LT-CAGE Lumbar Tapered
Fusion DeviceIDE Clinical ResultsG960065

• Hallett H. Mathews, M.D.Richmond, Virginia

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Important Findings

• Primary study objective met
• High fusion rates
• Shorter operative times and less blood
  loss
• Avoided complications and pain associated with
  bone graft harvesting

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InFUSEBone Graft versus Autograft Harvested
from Iliac Crest
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Clinical Trial Results
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Clinical Trial DesignOpen Surgical Approach

• Prospective, randomized controlled design
• Investigational Treatment -
  LT-CAGE Device / InFUSE Bone Graft
• Control Treatment -
  LT-CAGE Device / autogenous bone

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Study Objectives

• Primary Objective
• Equivalence in Overall Success

• Secondary Objectives

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Study Entrance Criteria

• Single level
• Symptomatic degenerative disc disease
• Inclusion/exclusion criteria

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Patient Evaluation

• Preoperatively
• Surgery/Discharge
• Postoperatively
• 6 Weeks, 3 Months, 6 Months
• 12 Months, 24 Months

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Patient Population

• Patients
• - 143 received InFUSE Bone Graft
• - 136 received autogenous bone graft
• 16 Investigational Centers

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Demographic Information

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Surgery Data

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Study Results Based
on 24-Month Data

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Overall Success

• Fusion
• ? 15 point improvement in Oswestry score
• Neurological maintenance or improvement
• No serious adverse event possibly associated to
  the device
• No second surgery failure

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Overall Success Rates
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Achieved Primary Objective
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Safety Overview

• Adverse events
• Second surgery procedures
• Antibody formation

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Adverse Events

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Adverse Events

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Comparison of Adverse Eventsin Investigational
and ControlTreatment Groups

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Differences noted in

• Graft Site Events -
• Occurred in 6 of control group
• None in investigational group

• Urogenital
• Resolved prior to discharge

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Adverse Events

• Typical for patient population
• Not unanticipated

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Second Surgery Procedures

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Classifications

• Revisions
• Removals
• Supplemental Fixations
• Reoperations
• Other

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Classifications

• Revisions - Failure
• Removals - Failure
• Supplemental Fixations - Failure
• Reoperations
• Other

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Second Surgeries

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Assessment of Antibody Formation

• rhBMP-2
• Bovine Type I Collagen
• Human Type I Collagen

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Comparision ofAuthentic Positive
ResponsesSimilar for both groups

• One patient in each group had positive response
  to rhBMP-2. (lt1)
• 13 in each group had positive response to bovine
  Type I collagen.
• None of these patients had positive results
  for human Type I collagen.

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Safety Summary

• Investigational and Control group rates
  are similar for
• Adverse events and second surgery
  procedures
  
• Antibody responses

InFUSE Bone Graft eliminates
graft harvesting adverse events
and pain
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• InFUSE Bone Graft / LT-CAGE
  Device
• Safe for its intended use

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Effectiveness OverviewInFUSE Bone Graft /
LT-CAGE Device patients had

• High fusion rates
• Pain relief
• Maintenance or improvement in neurological status

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Fusion

• Primary endpoint
• CT scans and radiographs utilized
• Two teams of independent reviewers

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Fusion Criteria

• Radiographic
• - Bridging trabecular bone
• - Segmental stability
• - Lucent line criteria
• No pseudarthrosis second surgery

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Fusion Success Rates
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Oswestry Low Back PainDisability Questionnaire

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Mean Oswestry Scores
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Oswestry Success 15 Point Improvement
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Neurological Status Measurements

• Motor Function
• Sensory
• Reflexes
• Straight Leg Raise

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Neurological Success Rates
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Secondary Effectiveness Endpoints

• Back pain
• Leg pain
• Disc height maintenance
• SF-36

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Back Pain Results - 24 Months
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Graft Site Pain in Control PatientsMean Scores
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Graft Site Appearance
in Control Patients

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Use of InFUSEBone Graft eliminates

• Negatives of Graft-site Appearance, Pain and
  Morbidity

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Laparoscopic Clinical Trial

• Data augment safety profile
• Supports approval of implantation method
• Identical protocol to open study
• 134 Investigational patients
• 14 Sites

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Surgery Data - Laparoscopic

• 2 days shorter hospital stay
• 45 treated on outpatient basis
• Returned to work 20 days sooner

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Overall Success Rates - Laparoscopic
Study
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Safety Results - Comparable to Open
Surgical Treatment Group
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Laparoscopic Versus Control 24 Months

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Fusion Success Rates - Laparoscopic
Study
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Case Histories

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Control Treatment Group

• 37 year old female
• L5 - S1 Level

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Control Treatment Group

• 38 year old female
• L5 - S1 Level

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Open Surgical Approach InFUSE Treatment Group

• 42 year old male
• L4 - L5 Level

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Open Surgical Approach InFUSE Treatment Group

• 36 year old male
• L5 - S1 Level

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As demonstrated in animal
and human studiesCT scans most practical and
definitive method for detecting bone formation
and determining fusion.
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Patient Satisfaction - 24 Months
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ConclusionsOpen Surgical ApproachClinical Trial

• Achieved Primary Objective - Overall Success Rate
  Statistically Equivalent to Control
• Benefits - Shorter Operative Times and Less Blood
  Loss than Control

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Important Benefits of InFUSE Bone Graft /
LT-CAGELumbar Tapered Fusion Device

• Induces bone formation
• Eliminates the need to harvest autogenous bone
  graft in spinal fusion procedures

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Conclusions - Laparoscopic Surgical Approach
Clinical Trial

• Achieved Primary Objective - Overall Success Rate
  Statistically Equivalent (and Superior) to
  Control
• Benefits - Shorter Hospital Stays and Faster
  Return to Work

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• InFUSE Bone Graft / LT-CAGE
• Lumbar Tapered Fusion Device
• SAFE AND EFFECTIVE

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