The CHARIT Artificial Disc

1
(No Transcript)
2
The CHARITÉ Artificial Disc

• Worlds 1st commercially available artificial
  disc
• Motion preserving technology for treating select
  patients with Degenerative Disc Disease (DDD)

3
Timeline

• 1st prototype,
• SB CHARITÉ I
• (13 Patients)
• 2nd prototype,
• SB CHARITÉ II
• (37 Patients)
• SB CHARITÉ III
• Available in Europe
• J.P. Lemaire,M.D. Study
• 100 Patients
• Min 10 Year Follow-up

• T. David, M.D. Study
• 96 Patients
• Min 5 Year Follow-up
• U.S. IDE
• Clinical Study
• First Implantation
• CENTRELINE
• Instruments
• Launched
• FDA Approval
• CENTRELINETM TDR Instruments Launched

1984 1985 1987 1989
1994 2000 2003 2004
4
Mobile-Core Design Translates to the Natural
Choice
5
Mobile-Core Design Translates to the Natural
Choice

• Natural motion by design
• Benefits of the unique mobile-core design
• Natural motion distribution may reduce adjacent
  level disease
• Biomechanical study
• Unique mobile-core design may protect facet
  joints
• FEA
• Mobile-core design translates to clinical success
• The living proof

6
Natural Motion by Design

• Unique mobile-core design
• Incorporates a floating center of rotation (FCOR)
  enabling independent rotation translation key,
  components of physiologic motion
• The mobile core moves dorsally during flexion and
  ventrally during extension

Demonstrated in Preclinical testing
7
Natural Motion Distribution May Reduce Adjacent
Level Disease

• The CHARITÉ mimicked the intact spine in
  distribution of motion
• Maintaining natural motion at all levels may
  reduce the potential of adjacent level disease

Cunningham BW, Godron JD, Dmitriev AE, et al
Biomechanical Evaluation of Total Disc
Replacement Arthroplasty An In Vitro Human
Cadaveric Model. Spine 28S110-S117, 2003. BAK
is a registered trademark of Zimmer, Inc.
8
Unique Mobile-Core DesignMay Protect Facet Joints

• FEA demonstrates that the CHARITÉ Artificial Disc
  unloads the facets in all planes of motion
• Compared to CHARITÉ, a fixed-core artificial disc
  increases the load of the facets
• 161 in axial rotation
• 24 in flexion/extension
• 35 in lateral bending

CHARITÉ
Fixed Core
Moumene M, Geisler FH. Effect of Artificial Disc
Placement on Facet Loading Unconstrained Vs.
Semi-constrained. Presented at the 4th
Annual Meeting of the Spine Arthroplasty Society,
May 5, 2004.
9
The Living Proof CHARITÉ Translates to Clinical
Success

• Unprecedented long-term results published by J.P.
  Lemaire, M.D. support that motion is maintained
  over 10 years after implantation
• Mean ROM 10.3º flexion/extension 5.4º lateral
  bending

Lemaire JP. SB Charité III intervertebral disc
prosthesis biomechanical, clinical, and
radiological correlations with a series of 100
cases over a follow-up of more than 10 years.
Rachis Fr 200214(4)271-85.
10
Unprecedented Clinical Results
11
Unprecedented Clinical Results

• Landmark U.S. clinical trial
• The CHARITÉ Artificial Disc was proven safe and
  effective for DDD at 1-level from L4-S1
• Patients experienced
• Improvement in pain and function
• Maintenance of motion
• Maintenance of post-operative disc height
• Similar safety profile compared to anterior
  interbody fusion
• Unparalleled long-term clinical history
• Over 17 years and thousands of implantations
  worldwide with the current design
• Proving safety, efficacy and remarkable
  durability

12
Patients Felt Better

• Compared to baseline, the CHARITÉ Artificial Disc
  provided pain reduction from 6 weeks out to 24
  months
• Patients with the CHARITÉ Artificial Disc
  exhibited
• 49 decrease in 6-weeks
• 57 decrease by 24-months

Blumenthal S, McAfee P, Guyer R, Hochschuler S,
Garcia R, Regan J, Ohnmeiss D. Randomized
Control Trial of the Charite Artificial Disc vs
Fusion for Single Level Lumbar Degenerative Disc
Disease Two year Follow-up. Presented at the
31st Annual Meeting of the International Society
for the Study of the Lumbar Spine (ISSLS). Porto,
Portugal, 2004. BAK is a registered trademark of
Zimmer, Inc.
13
Improvement in Pain and Function

• Compared to baseline, the CHARITÉ Artificial Disc
  provided improvement in pain and function from 6
  weeks out to 24 months
• Patients with the CHARITÉ Artificial Disc
  exhibited
• 25 decrease in 6-weeks
• 48 decrease by 24-months

14
Improvement in Pain and Function

• 78 of patients with the CHARITÉ Artificial Disc
  had at least a 10 point change in ODI

15
Maintained Motion

• The CHARITÉ Artificial Disc allowed segmental
  spinal motion at the operative level

16
Maintained Disc Height

• The CHARITÉ Artificial Disc provided maintenance
  of post-operative disc height of 12.9mm at
  24-months

17
Patient Satisfaction

• At 24 months, 74 of the patients with the
  CHARITÉ Artificial Disc were satisfied

18
Demonstrated Safety

• Similar Neurological complications were observed
  with the the CHARITÉ Artificial Disc

Major Changes burning or dysesthetic pain, motor
deficit in index level, and nerve root injury
19
Unprecedented Long-term Results

• Landmark study of 100 patients with a minimum of
  10 years follow-up by J.P Lemaire, M.D.
  demonstrates unprecedented results
• Excellent Patient Satisfaction
• 90 good/excellent results
• Motion Preservation
• 10.3º mean ROM flexion/extension
• 5.4 º mean ROM lateral bending
• Quality of Life
• 92 return to work
• Minimal Adjacent Level Disease
• 2 adjacent level disease

Lemaire JP. SB Charité III intervertebral disc
prosthesis biomechanical, clinical, and
radiological correlations with a series of 100
cases over a follow-up of more than 10 years.
Rachis Fr 200214(4)271-85.
20
Unprecedented Long-term Results

• Landmark study by T. David, M.D. further supports
  long-term efficacy
• 96 patients with a minimum of 5years follow-up
• Excellent Patient Satisfaction
• 75 good/excellent results
• Disc Height Maintenance
• No loss of height
• No Device Related Complications
• No loosening of the UHMWPE Sliding Core

David T. Lumbar Disc Prosthesis Five Years
Follow-Up Study on 96 Patients. Presented at the
15th Annual Meeting of the North American Spine
Society. New Orleans, Louisiana, 2000.
21
Remarkable Durability
22
Remarkable Durability

• The CHARITÉ Artificial Disc, which is comprised
  of cobalt chromium Endplates and Ultra High
  Molecular Weight Polyethylene (UHMWPE) Sliding
  Core, exhibits remarkable durability with
• A potential reduction in wear due to the
  mobile-core design
• Low wear rates in biomechanical testing
• No localized or systemic accumulation of wear
  debris
• No evidence of acute neural or systemic
  histopathologic response

23
Mobile-Core May Reduce Wear Potential

• FEA demonstrates mobile-core design exhibits low
  stresses on the Endplates and Sliding Core
• May significantly reduce wear potential
• Under equivalent strain, a fixed-core artificial
  disc shows significantly higher stress
• May lead to greater potential for wear

3Mpa
CHARITÉ
24Mpa
Fixed Core
Moumene M, Geisler FH. Effect of Artificial Disc
Placement on Facet Loading Unconstrained Vs.
Semi-constrained. Presented at the 4th
Annual Meeting of the Spine Arthroplasty Society,
May 5, 2004.
24
CHARITÉ. Significantly Lower Wear Compared to
Other Arthroplasty Prostheses

• Bench top testing data to10 million cycles
• Reportedly 80 years of vigorous motion
• Sliding Core wore at the rate of 0.11mg/Mc
  compared to 56mg/MC non-crosslinked Hip and
  16mg/Mc crosslinked hip

Heisel C, Silva M, dela Rosa MA, et al.
Short-term in vivo wear of cross-linked
polyethylene. J Bone Joint Surg Am
200486-A748-51. Data on file
25
Wear Debris Pre-Clinical Testing

• No local or systemic accumulation of particulate
  wear debris nor cytokines
• Baboon biomechanical study
• Under extreme exposure to UHMWPE wear
  particulate, no evidence of acute neural or
  systemic histopathologic response
• Rabbit studies

McAfee PC, Cunningham BW, Orbegoso CM, et al.
Analysis of porous ingrowth in intervertebral
disc prostheses a nonhuman primate model. Spine
200328(4)332-40. Cunningham BW, Hallab N,
Dimitriev A, Kim SW, Hu N, McAfee PC. Epidural
Application of Spinal Instrumentation Particulate
Wear Debris An In-Vitro Animal Model. Presented
at the 38th Annual Meeting of the Scoliosis
Research Society. Quebec, Canada, 2003.
26
Refined Surgical Procedure
27
Refined Surgical Procedure

• 17 years of clinical experience and refinements
  have led to todays CHARITÉ Artificial Disc
  System
• Designed to replicate the patients natural
  anatomic alignment
• Exceptional biomechanical design
• Unparalleled range of endplates and core heights
• Numerous options to help ensure proper sizing,
  placement and segmental lordosis
• New CENTRELINE TDR Instrumentation for
  consistent and accurate sizing and midline
  placement for a refined surgical technique

28
Range of Implant Options to Match Your Patients
Anatomy

• UHMWPE Sliding Core available in 5 heights
  (7.5-11.5mm) for restoration of desired disc
  height
• Endplates available in four sizes angles for
  proper sizing and restoration of segmental
  lordosis

29
Intra-operative Flexibility

• Angled Endplate may be placed inferiorly to help
  reduce shear forces and protect the implant and
  posterior elements
• The Endplate fixation teeth maintain the
  integrity of the vertebral body and allow for
  intra-operative adjustment and removal of the
  CHARITÉ Artificial Disc

30
CENTRELINE TDR Instrumentation

• New CENTRELINE TDR Instrumentation aids in
• consistent and accurate sizing and midline
  placement for optimal performance
• Six Steps of Implantation

31
6 Steps of ImplantationStep 1 Trialing

• Confirm footprint size (2-5) using the Sizing
  Gauges
• Confirm lordotic angle with the radiolucent
  Trials
• Verify proper placement

Maximize endplate coverage
32
Step 2 Midline Identification

• Place Midline Marker using the Marker Inserter

33
Step 3 Confirm Positioning

• Confirm ability to place the CHARITÉ Artificial
  Disc in the proper location with the Pilot Driver
• If needed, increase lordosis to initiate
  impaction
• Shape curved surfaces prior to impaction
• Place patient in neutral spine position when
  Pilot Driver is halfway into position

Approximately matches footprint size and height
of 2 Endplates
34
Step 4 Endplate Insertion

• Insert Endplates into disc space using the
  Spreading and Insertion Forceps
• Load thicker margin of oblique Endplate into the
  tips first
• Place the more angled of the two Endplates
  inferiorly

35
Step 5 Core Trial and Insertion

• Confirm proper height with the Core Trials
• Insert Sliding Core with the Core Insertion
  Instrument

36
Step 6 Final Positioning

• Verify proper positioning in the AP and lateral
  planes

37
Delivering Excellent Results

• Treatment of degenerative lumbar disc disease
  does not depend solely on the CHARITÉ Artificial
  Disc
• Other important considerations include
• Completion of a company sponsored training
  program
• Proper patient selection
• Safe and adequate surgical approach and exposure
  to the appropriate degenerative disc level
• Complete discectomy and meticulous endplate
  preparation
• Proper implant selection and placement

38
Natural Motion Is Back.

• The Natural Choice
• Preclinical testing indicates that the unique
  mobile-core design incorporates a FCOR, enabling
  independent translation and rotation, key
  components of physiologic motion
• Unprecedented Clinical Results
• The CHARITÉ has an unparalleled long-term
  clinical history proving safety, efficacy and
  remarkable durability with over 17 years and
  thousands of implantations worldwide with the
  current design

39
Natural Motion Is Back.

• Remarkable Durability
• Significantly lower wear compared to other
  arthroplasty prostheses
• Refined Surgical Procedure
• 17 years of clinical experience and refinements
  have led to todays CHARITÉ Artificial Disc
  System

40
Indications

• The CHARITÉ Artificial Disc is indicated for
  spinal arthroplasty in skeletally mature patients
  with degenerative disc disease (DDD) at one level
  from L4-S1. DDD is defined as discogenic back
  pain with degeneration of the disc confirmed by
  patient history and radiographic studies. These
  DDD patients should have no more than 3mm of
  spondylolisthesis at the involved level. Patients
  receiving the CHARITÉ Artificial Disc should have
  failed at least six months of conservative
  treatment prior to implantation of the CHARITÉ
  Artificial Disc.