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Lumbar Arthroplasty CHARITÉ® Artificial Disc Physician Name Physician Institution Date.

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1 Lumbar Arthroplasty CHARITÉ® Artificial Disc Physician Name Physician Institution Date

2 Agenda Data Review Preclinical: Design and Durability Investigational Device Exemption (IDE) Trial Revision Long-term Results Questions and Answers

3 Goals of Lumbar Total Disc Replacement To maintain segmental spinal motion To provide pain relief and increased patient activity To restore disc height and lordosis To eliminate postoperative fusion problems, such as Bone graft donor site pain Pseudarthrosis

4 Design: Total Disc Replacement Mobile-core design Preclinical testing indicates that the unique mobile-core design of the CHARITÉ Artificial Disc is intended to mimic the motion of the operative spinal segment, maintain segmental stability, restore proper disc height, and re- establish lordotic alignment Fixed-core design Fixed axis (nonfloating) center of rotation Translation is never independent from rotation Demonstrated in preclinical testing. Dilip K. Sengupta, MD, PhD

5 Design: Biomechanical Testing – Translation of the Mobile Core Cadaveric study by Cunningham et al demonstrates that the CHARITÉ Artificial Disc preserves the kinematics of the intact disc Mobile core reproduces natural segmental translation Translation is independent of rotation Mobile core reproduces natural floating center of rotation Intact spine CHARITÉ Artificial Disc Avg 2.06 (.77) mm Avg 1.9 (.98) mm Intact spine Cunningham BW et al. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine. 2003;28:S110-S117.

6 Biomechanical Evaluation of Total Disc Replacement Arthroplasty: An In Vitro Human Cadaveric Model Cunningham et al The CHARITÉ Artificial Disc mimicked the intact spine in distribution of motion at both the operative and adjacent levels This study suggests that natural motion may reduce adjacent-level disease Cunningham BW et al. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine. 2003;28:S110-S117. BAK is a registered trademark of Zimmer, Inc.

7 Incidence of Adjacent-level Disease: Fusion Literature Loss of motion in the operative levels can result in stress and increased motion in the segments adjacent to the fused level1-3 This stress and increased motion at adjacent levels may lead to adjacent- level disease with rates of incidence as high as 35%-41%4-9 In a series of 106 lumbar fusion patients with 2 to 15 years follow-up, Gillet reported a 20% reoperation rate for symptomatic lumbar adjacent-level disease6 In a series of 215 lumbar fusion patients with a mean follow-up of 6.7 years, Ghiselli et al reported a reoperation rate of 27.4% with a predicted rate of reoperation for adjacent-level disease of 36.1% at 10 years, following lumbar fusion surgery9 1 Cunningham BW et al. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine. 2003;28:S110-S Huang RC et al. The implications of constraint in lumbar total disc replacement. J Spinal Disord Tech. 2003;16: Chosa E et al. Analysis of the effect of lumbar spine fusion on the superior adjacent intervertebral disk in the presence of disk degeneration using the three-dimensional finite element method. J Spinal Disord Tech. 2004;17: Throckmorton TW et al. The impact of adjacent level disc degeneration on health status outcomes following lumbar fusion. Spine. 2003;28: Chen WJ et al. Surgical treatment of adjacent instability after lumbar spine fusion. Spine. 2001;26:E519-E Gillet P. The fate of the adjacent motion segments after lumbar fusion. J Spinal Disord Tech. 2003;16: Kumar MN et al. Correlation between sagittal plane changes and adjacent segment degeneration following lumbar spine fusion. Eur Spine J. 2001;10: Rahm MD et al. Adjacent-segment degeneration after lumbar fusion with instrumentation: a retrospective study. J Spinal Disord Tech. 1996;9: Ghiselli G et al. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004;86-A:

8 Incidence of Adjacent-level Disease: Long-term CHARITÉ Artificial Disc Clinical Results J. P. Lemaire, MD, et al1 100 patients Minimum of 10-year follow-up 2% adjacent-level disease Thierry David, MD2 106 patients Minimum of 10-year follow-up 3% adjacent-level disease 1Lemaire JP et al. Clinical and radiological outcomes with the Charité Artificial Disc: a 10-year minimum follow-up. J Spinal Disord Tech. 2005;18: David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITÉ Artificial Disc in 106 patients. Spine. 2007;32(6).

9 Effect of Artificial Disc Placement on Facet Loading: Unconstrained vs Semiconstrained Moumene et al Finite Element Analysis demonstrates that the CHARITÉ Artificial Disc unloads the facets in all planes of motion Compared with the CHARITÉ Artificial Disc, a fixed-core artificial disc increases facet loads 161% in axial rotation 24% in flexion/extension 35% in lateral bending (under displacement control conditions at L4-L5) Design may protect facet joints Model validated to Panjabis data CHARITÉ Artificial Disc Fixed core Moumene M et al. Effect of artificial disc placement on facet loading: unconstrained vs. semi- constrained. Presented at the 4th Annual Meeting of the Spine Arthroplasty Society, May Comp. Stress

10 Durability: The Effects of Design Moumene et al Finite Element Analysis demonstrates mobile-core design may exhibit 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 3 Mpa 24 Mpa Moumene M et al. Effect of artificial disc placement on facet loading: unconstrained vs. semi-constrained. Presented at the 4th Annual Meeting of the Spine Arthroplasty Society, May CHARITÉ Artificial Disc Fixed core Comp. Stress

11 Durability: Material Biocompatability Analysis of porous ingrowth in intervertebral disc prostheses: a nonhuman primate model McAfee et al1 6-month survival study No local accumulation of particulate wear debris nor cytokines Epidural application of spinal instrumentation particulate wear debris: an in vitro animal model Cunningham et al2 6-month survival study Under extreme exposure to ultra-high molecular weight polyethylene (UHMWPE) wear particulate, no evidence of acute neural or systemic histopathologic response 1McAfee PC et al. Analysis of porous ingrowth in intervertebral disc prostheses: a nonhuman primate model. Spine. 2003;28: Cunningham BW. Basic scientific considerations in total disc arthroplasty. Spine J. 2004;4(6S):219S-230S.

12 Materials: Changes in UHMWPE UHMWPE joints show reduced wear and better performance when oxidation is reduced (Collier 2003) Material performance 2000 (wire change) X-ray wire optimized to allow flexibility to eliminate breaks No known failures of new wire 2004 (packaging change) GVF (foil pkg) greatly reduces shelf oxidation (Greer 1999) Proven track record in DePuy hips and knees Provides better creep resistance than highly x-linked Provides better toughness more than highly x-linked Days in Package Reactivity to Oxidation GVF at RT (same lot) G-Air-1,16, & 40 mos. GVF-1,16, 40, & 50 mos.

13 Summary: Biomechanics The CHARITÉ Artificial Disc mimics the intact spine, enabling independent rotation and translation Motion may reduce the potential of adjacent-level disease Mobile-core design may significantly reduce wear potential Biocompatibility (animal studies) No local or systemic accumulation of particulate wear debris, nor cytokines, were detected No evidence of acute neural or systemic histopathological response found under extreme exposure to UHMWPE wear particulate

14 Agenda Data Review Preclinical: Design and Durability IDE Trial Revision Long-term Results Questions and Answers

15 IDE Trial: CHARITÉ Artificial Disc IDE study results published in July 2005 Multicenter, prospective, randomized, controlled study to compare 2 different surgical treatments for lumbar degenerative disc disease (DDD) A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part I: evaluation of clinical outcomes Scott Blumenthal MD, Paul C. McAfee MD, Richard D. Guyer MD, Stephen H. Hochschuler MD, Fred H. Geisler MD, PhD, Richard T. Holt MD, Rolando Garcia Jr. MD, MPH, John J. Regan MD and Donna Ohnmeiss PhD A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes Paul C. McAfee MD, Bryan Cunningham Mmech Eng, Gwen Holsapple BS, Karen Adams BS, Scott Blumenthal MD, Richard D. Guyer MD, Anton Dimitriev MS, James H Maxwell MD, John J. Regan MD and Jorge Isaza MD

16 IDE Trial: CHARITÉ Artificial Disc Level 1 Data24 Months At 24 months, the CHARITÉ Artificial Disc was demonstrated to be safe and effective for DDD at 1 level from L4-S1 High patient satisfaction At 24 months, 74% of patients with the CHARITÉ Artificial Disc were satisfied versus 53% of fusion patients At 24 months, the CHARITÉ Artificial Disc maintained motion Allowed segmental spinal motion at the operative level versus loss of motion in the fusion patients Improvement in pain and function 71.0% achieved a 25% improvement in Oswetry Disability Index (ODI) scores compared to baseline versus 62.0% in the control group 78% had at least a 10-pt. change in ODI 0% psuedoarthrosis versus 9.1% in the control group 0% bone graft donor pain versus 18.2% in the control group Blumenthal SL et al. A prospective randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine. 2005;301: McAfee PC et al. A prospective randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine. 2005;30:

17 BAK as the Control FDA requires that IDE study-control groups incorporate only FDA-approved devices A meta-analysis of the fusion literature included 25 papers and 29 separate data sets with 360º fusion involving anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), or transforaminal lumbar interbody fusion (TLIF), and stand-alone fusion with ALIF or PLIF CHARITÉ Artificial Disc compared favorably in mean change in ODI and visual analog scores (VAS) to all other treatments Comparing the clinical results as measured by ODI, BAK subjects in the CHARITÉ Artificial Disc trial performed similarly to 360º fusion subjects from the ProDisc® trial Geisler FH et al. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. J Neurosurg Spine. 2004;1:

18 *Pain scale scores were converted to VAS score equivalent. Geisler FH. Spine Arthroplasty Summit, Salt Lake City, February HH = Harshill horseshoe cage; IntFix = internal fixation; LT = LT-Cage. CHARITÉ Artificial Disc vs Stand-alone Interbody Fusion Authors & Year No. of Cases Approach/ Instrumentation % Change in Mean VAS (799 patients) Change in Mean ODI (1186 patients) Pfeiffer et al, ALIF w/ auto-35.7 Tiusanen et al, ALIF w/ auto-18.3 Kuslich et al, 1998*299BAK ALIF + BAK/PLIF-41.2 Kuslich et al, BAK ALIF + BAK/PLIF-44.8 Madan & Boeree et al, ALIF w/ HH Burkus et al, 2002A22Allo BD auto ALIF Burkus et al, 2002A24Allo BD BMP-2 ALIF Burkus et al, 2002B108LT auto ALIF LT BMP-2 ALIF ALIF w/ IntFix-21.6 Pellise et al, ALIF w/ Br-69.2 Beutler & Peppelman, BAK ALIF-24.0 Burkus et al, LT auto ALIF LT BMP-2 ALIF-31.3 Sasso et al, FRALIF-21.2 Weighted mean CHARIT É IDE Study n= Results of meta-analysis involving studies in which ODI and VAS scores were reported: stand-alone ALIF or PLIF INFUSE IDE

19 CHARITÉ Artificial Disc vs 360°Fusion Results of meta-analysis involving studies in which ODI and VAS scores were reported: 360° fusion via ALIF, PLIF, or TLIF8 Authors & Year No. of Cases Approach/ Instrumentation % Change in Mean VAS (591 patients) Change in Mean ODI (162 patients) Soini, FRALIF ExtPed Gertzbein et al, FRALIF-70.4 Hinkley & Jaremko, AlloBDauto ALIF-14.1 Gertzbein et al, FRALIF-40.5 Whitecloud et al, Mesh ALIF-23.6 Leufven & Nordwall, Auto PLIF-61.6 Tandon et al, Br PLIF-12.1 Barrick et al, Delayed FRALIF Brantigan et al, Br PLIF-60.0 Thalgott et al, Mix ALIF-56.0 Lowe et al, Mesh TLIF-61.4 Thalgott et al, ALIF Thalgott et al, Mesh ALIF-57.3 Madan, Mix PLIF Weighted mean CHARIT É IDE Study n= Allo = allograft; AlloBDauto = allograft bone dowels filled with autograft; auto = autograft; Br = Brantigan Cage; ExtPed = external transpedicular fixation; FRALIF = femoral ring allograft ALIF; mesh = titanium mesh cage; mix = mixed grafts. Table Adapted From: Geisler FH et al. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. J Neurosurg Spine. 2004;1: Geisler FH et al. Spine Arthroplasty Summit, Salt Lake City, February 2006.

20 IDE Trial: Statistical Analysis

21 IDE Trial: Alternative Statistical Analysis What is clinically significant improvement? ODI reduction of 10 points VAS reduction of points Why is the Wilcoxon Rank Sum Test the appropriate statistical test? Nonparametric test for non-normally distributed data Hägg et al. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12:12–21. VASODI 2 Years Follow-up Non-Normal Distribution All CHARITÉ Artificial Disc and BAK Patients n=375

22 ODI CHARITÉ Artificial Disc vs Control Wilcoxon Rank Sum Test. Geisler FH et al. Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical outcomes at 2 years vs. fusion for the treatment of one-level lumbar degenerative disc disease at L4-5 or L5-S1. Presented at SAS6, Montreal, May Preop6 wk3 mo6 mo12 mo24 mo Follow-up Time Point Mean ODI (Function) Score CHARITÉ Artificial Disc ReplacementFusion Control P= P= P= P= * * * * * n=375

23 VAS CHARITÉ Artificial Disc vs Control P=0.0030P= P= P= P= * * * * * Preop6 wk3 mo6 mo12 mo24 mo Mean VAS (Pain) Score Wilcoxon Rank Sum Test. Geisler FH et al. Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical outcomes at 2 years vs. fusion for the treatment of one-level lumbar degenerative disc disease at L4-5 or L5-S1. Presented at SAS6, Montreal, May n=375 Follow-up Time Point CHARITÉ Artificial Disc ReplacementFusion Control

24 Wilcoxon Rank Sum Test In this analysis, patients treated with the CHARITÉ Artificial Disc had statistically better clinical outcomes, as measured by ODI and VAS at all time points, compared to the BAK fusion control group P<0.05 at all time points including 2 years Highly significant improvement in pain and function at all time points compared to baseline Geisler FH et al. Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical outcomes at 2 years vs. fusion for the treatment of one-level lumbar degenerative disc disease at L4-5 or L5-S1. Presented at SAS6, Montreal, May 2006.

25 Patient Selection: The Effects of Age on Clinical Outcomes Ages 18–45 vs 46–60

26 ODI Outcomes Based on Age P= Preop6 wk3 mo6 mo12 mo24 mo Follow-up Ages 18-45Ages Mean ODI Scores Using Students t Test. Guyer RG et al. One-level lumbar arthroplasty in patients years of age vs. patients years of age: is there a difference in clinical outcome? Presented at the annual meeting of the North America Spine Society, Seattle, September 2006.

27 VAS Outcomes Based on Age Using Students t Test. Guyer RG et al. One-level lumbar arthroplasty in patients years of age vs. patients years of age: is there a difference in clinical outcome? Presented at the annual meeting of the North America Spine Society, Seattle, September Mean VAS Scores P= Preop6 wk3 mo6 mo12 mo24 mo Follow-up Ages 18-45Ages 46-60

28 Outcomes Based on Age Patient Satisfaction Using Students t Test. Guyer RG et al. One-level lumbar arthroplasty in patients years of age vs. patients years of age: is there a difference in clinical outcome? Presented at the annual meeting of the North America Spine Society, Seattle, September Ages 18-45Ages SatisfiedSomewhat Satisfied Somewhat Dissatisfied Percent 87% Satisfied/somewhat satisfied 85% Satisfied/somewhat satisfied

29 Outcomes Based on Age Range of Motion P= Preop3 mo6 mo12 mo24 mo Flex/Ext ROM (deg) Using Students t Test. Guyer RG et al. One-level lumbar arthroplasty in patients years of age vs. patients years of age: is there a difference in clinical outcome? Presented at the annual meeting of the North America Spine Society, Seattle, September Follow-up Ages Ages 46-60

30 IDE Trial: Clinical Outcomes Based on Age Comparator groups ages versus No statistical difference in VAS, ODI, patient satisfaction, and ROM at 24 months Higher incidence of osteoporosis and osteopenia in older patients requires preoperative screening If older patients are otherwise indicated for total disc replacement, age alone up to age 60 should have no effect on their clinical outcome

31 Summary: IDE Trial Level I data supporting safety and efficacy at 24 months in the treatment of DDD at 1 level from L4 to S1 In the IDE trial, 74% of the patients with the CHARITÉ Artificial Disc exhibited high levels of satisfaction, maintained motion, and showed improvement in pain and function, as measured by the VAS at 24 months and compared to baseline Significantly better clinical outcomes in terms of VAS and ODI scores compared to function at all time points through 24 months, using an alternative statistical method from that used in the original analysis of the IDE study data (ie, Wilcoxon Rank Sum Test)

32 Agenda Data Review Preclinical: Design & Durability IDE Trial Revision Long-term Results Questions & Answers

33 Published Worldwide Revision Rates Worldwide third-generation CHARITÉ Artificial Disc JP Lemaire, MD1 : reported rate of 5% (in 100 patients with a maximum of 10-years follow-up) M Scott-Young, MD2: reported rate of 2.7% (in a series of 182 patients over 7 years) United States clinical trial3,4 5.4% of CHARITÉ Artificial Disc implanted patients versus 9.1% of fusion patients Similar complications were observed with the CHARITÉ Artificial Disc and BAK procedures No significant difference in complication rate between the CHARITÉ Artificial Disc and the control group 1Lemaire JP et al. Clinical and radiological outcomes with the Charité Artificial Disc: a 10-year minimum follow-up. J Spinal Disord Tech. 2005;18: Scott-Young, M. Revision strategies for lumbar disc replacement. Presented at the annual meeting of the North American Spine Society, September Spine J. 2004;4: Blumenthal SL et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part I - evaluation of clinical outcomes. Spine. 2005;30: McAfee PC et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine. 2005;30:

34 Revision Strategies and Fixation Primary revision strategy is instrumented posterolateral lumbar fusion Prosthesis acts as an anterior column spacer Posterior pedicle screw fixation combined with CHARITÉ Artificial Disc was shown to be not statistically different from pedicle screws combined with femoral ring allograft Cunningham BW et al. Multidirectional flexibility properties of single versus multi-level CHARITÉ total disc arthroplasty – an emphasis on revision strategies. Presented at SAS5, New York, May 2005.

35 Revision Strategies and Fixation Endplate fixation teeth Vertebral body sparing The teeth, as compared to a keel, allow intraoperative adjustment and removal for proper positioning Preserves the possibility of revision with (TDR) Keel design No ability to revise with TDR burns the bridge Difficult to revise, may require a corpectomy No ability to adjust positioning Proper positioning has been correlated with improved clinical outcomes in the Charite Artificial Disc trial1 Possibility of fracturing endplate during insertion2 1. McAfee PC et al. A prospective randomized, multicenter food and drug administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part II - evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine. 2005;30: Shim CS et al. Vertical split fracture of the vertebral body following total disc replacement using ProDisc: report of two cases. J Spinal Disord Tech. 2005;18:

36 5-Year Implant Survivorship Analysis

37 Kaplan-Meier regression analysis to predict rate of 5-year implant survivorship 8 high-enrolling sites N=1938 CHARITÉ patients from 5 countries N=56 BAK fusion patients from 4 IDE sites Methods McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March 2007.

38 5-Year Implant Survivorship Analysis CHARITÉ Artificial Disc implant predicted to have a longer implant survival profile Significant difference in implant survivorship in the CHARITÉ Artificial Disc group (93.1%), as compared to the fusion group (80.1%) p= Implant survivorship = no reoperation of any kind at the index level The rate of adjacent-level disease requiring reoperation was significantly less in the CHARITÉ Artificial Disc group 4.4% compared to the BAK cage fusion group 11.0% (p=0.0350) McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March 2007.

39 5-Year Implant Survivorship Analysis McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March 2007.

40 5-Year Implant Survivorship Analysis McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March P=0.0034

41 5-Year Adjacent-Level Survivorship Analysis McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March P=0.0350

42 Summary: Revision Primary revision strategy is instrumented posterolateral lumbar fusion 5-year implant survivorship analysis Significant difference in survivorship in CHARITÉ Artificial Disc group (93.41), as compared to the fusion group (80.1%) at 5 years (P=0.003)

43 Agenda Data Review Precinical: Design and Durability IDE Trial Revision Long-term Results Questions and Answers

44 Lumbar Disc Prosthesis: Minimum 5-Year Follow-up Study on 96 Patients (With Current Design) T. David, MD 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 annual meeting of the North American Spine Society, New Orleans, Louisiana, October 2000.

45 Clinical and Radiological Outcomes With the CHARITÉ Artificial Disc: A 10-Year Minimum Follow-up (With Current Design) J. P. Lemaire MD, et al 100 patients with a minimum of 10-year follow-up Excellent patient satisfaction 90% good/excellent results Motion preservation 10.3º mean ROM flexion/extension 5.4º mean ROM lateral bending Quality of life 92% return to work Minimal adjacent-level disease 2% adjacent-level disease Lemaire JP et al. Clinical and radiological outcomes with the Charité Artificial Disc: a 10-year minimum follow-up. J Spinal Disord Tech. 2005;18:

46 16-Year Experience Thierry David, MD Single-level DDD Minimum 10-year follow-up in 106 pts 82% excellent/good clinical outcomes 90% return to work 7% secondary fusion 3% adjacent-level disease Mean F/E ROM 10.1° 90% of the prostheses were still mobile 10-year postop F/E: 19° (+5,+14) Lateral: 11° (+8,+3) David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITÉ Artificial Disc in 106 Patients. Spine. 2007;32(6):661-6.

47 Summary: Long-term Results (With Current Design) T. David, MD, 5-year follow-up study on 96 patients 75% good/excellent results J. P. Lemaire, MD, 10-year follow-up study with 100 patients 90% good/excellent results 2% adjacent-level disease T. David, MD, minimum 10-year follow-up in 106 patients 82% excellent/good clinical outcomes 3% adjacent-level disease

48 CHARITÉ® ARTIFICIAL DISC 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.

49 Questions and Answers

50 References In Order of Appearance Cunningham BW et al. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine. 2003;28:S110-S117. Huang RC et al. The implications of constraint in lumbar total disc replacement. J Spinal Disord Tech. 2003;16: Chosa E et al. Analysis of the effect of lumbar spine fusion on the superior adjacent intervertebral disk in the presence of disk degeneration using the three-dimensional finite element method. J Spinal Disord Tech. 2004;17: Throckmorton TW et al. The impact of adjacent level disc degeneration on health status outcomes following lumbar fusion. Spine. 2003;28: Chen WJ et al. Surgical treatment of adjacent instability after lumbar spine fusion. Spine. 2001;26:E519-E524. Gillet P. The fate of the adjacent motion segments after lumbar fusion. J Spinal Disord Tech. 2003;16: Kumar MN et al. Correlation between sagittal plane changes and adjacent segment degeneration following lumbar spine fusion. Eur Spine J. 2001;10: Rahm MD et al. Adjacent-segment degeneration after lumbar fusion with instrumentation: a retrospective study. J Spinal Disord Tech. 1996;9: Ghiselli G et al. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004;86-A: Lemaire JP et al. Clinical and radiological outcomes with the Charit é Artificial Disc: a 10-year minimum follow-up. J Spinal Disord Tech. 2005;18: David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARIT É Artificial Disc in 106 patients. Spine. 2007;32(6). Moumene M et al. Effect of artificial disc placement on facet loading: unconstrained vs. semi-constrained. Presented at the 4th Annual Meeting of the Spine Arthroplasty Society, May McAfee PC et al. Analysis of porous ingrowth in intervertebral disc prostheses: a nonhuman primate model. Spine. 2003;28: Cunningham BW. Basic scientific considerations in total disc arthroplasty. Spine J. 2004;4(6S):219S-230S. Blumenthal SL et al. A prospective randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc replacement with the CHARIT É Artificial Disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine. 2005;30:

51 References In Order of Appearance McAfee PC et al. A prospective randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc replacement with the CHARIT É Artificial Disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine. 2005;30: Geisler FH et al. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charit é intervertebral disc. J Neurosurg Spine. 2004;1: Geisler FH. Spine Arthroplasty Summit, Salt Lake City, February H ä gg et al. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12:12 – 21. Geisler FH et al. Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical outcomes at 2 years vs. fusion for the treatment of one-level lumbar degenerative disc disease at L4-5 or L5-S1. Presented at SAS6, Montreal, May Guyer RG et al. One-level lumbar arthroplasty in patients years of age vs. patients years of age: is there a difference in clinical outcome? Presented at the annual meeting of the North America Spine Society, Seattle, September Van Ooij A et al. Complications of artificial disc replacement: a report of 27 patients with the SB Charite disc. J Spinal Disord Tech. 2003;16: Scott-Young, M. Revision strategies for lumbar disc replacement. Presented at the annual meeting of the North American Spine Society, September Spine. 2004;4:1155. Cunningham BW et al. Multidirectional flexibility properties of single versus multi-level CHARIT É total disc arthroplasty – an emphasis on revision strategies. Presented at SAS5, New York, May Shim CS et al. Vertical split fracture of the vertebral body following total disc replacement using ProDisc: report of two cases. J Spinal Disord Tech. 2005;18: McAfee et al. Predicted 5-year implant survivorship of the CHARIT É Artificial Disc vs. anterior lumbar interbody fusion: a Kaplan-Meier analysis. Presented at IMAST, Rome, July David T. Lumbar disc prosthesis: five years follow-up study on 96 patients. Presented at the annual meeting of the North American Spine Society, New Orleans, Louisiana, October 2000.

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