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The CHARITÉ™ Artificial Disc
World’s 1st commercially available artificial disc Motion preserving technology for treating select patients with Degenerative Disc Disease (DDD) DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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Timeline 1984 1985 1987 1989 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 1994 2000 2003 2004 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
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Mobile-Core Design Translates to the Natural Choice
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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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 28:S110-S117, 2003. BAK® is a registered trademark of Zimmer, Inc. DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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Unique Mobile-Core Design May 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. DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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] 2002;14(4): DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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Unprecedented Clinical Results
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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
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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.
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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
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Improvement in Pain and Function
78% of patients with the CHARITÉ Artificial Disc had at least a 10 point change in ODI Change in ODI CHARITÉ BAK® Follow-up 2 yr > -15 pt 64% 58% -15 to -10 pt 14% 9% Total ≧ -10 pt 78% 67%
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Maintained Motion The CHARITÉ Artificial Disc allowed segmental spinal motion at the operative level
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Maintained Disc Height
The CHARITÉ Artificial Disc provided maintenance of post-operative disc height of 12.9mm at 24-months
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Patient Satisfaction At 24 months, 74% of the patients with the CHARITÉ Artificial Disc were satisfied
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Demonstrated Safety Similar Neurological complications were observed with the the CHARITÉ Artificial Disc Neurological Results CHARITÉ BAK® Major Changes 4.4 4.0 Minor changes 13.7 16.2 Major Changes: burning or dysesthetic pain, motor deficit in index level, and nerve root injury
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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] 2002;14(4):
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Unprecedented Long-term Results
Landmark study by T. David, M.D. further supports long-term efficacy 96 patients with a minimum of 5–years 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.
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Remarkable Durability
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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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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. DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 2004;86-A: Data on file DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 2003;28(4): 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. DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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Refined Surgical Procedure
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Refined Surgical Procedure
17 years of clinical experience and refinements have led to today’s CHARITÉ Artificial Disc System Designed to replicate the patient’s 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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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Range of Implant Options to Match Your Patients’ Anatomy
UHMWPE Sliding Core available in 5 heights ( mm) for restoration of desired disc height Endplates available in four sizes & angles for proper sizing and restoration of segmental lordosis DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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CENTRELINE™ TDR Instrumentation
New CENTRELINE™ TDR Instrumentation aids in consistent and accurate sizing and midline placement for optimal performance Six Steps of Implantation DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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6 Steps of Implantation Step 1 Trialing
Confirm footprint size (2-5) using the Sizing Gauges Confirm lordotic angle with the radiolucent Trials Verify proper placement Maximize endplate coverage DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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Step 2 Midline Identification
Place Midline Marker using the Marker Inserter DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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Step 5 Core Trial and Insertion
Confirm proper height with the Core Trials Insert Sliding Core with the Core Insertion Instrument DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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Step 6 Final Positioning
Verify proper positioning in the AP and lateral planes DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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 today’s CHARITÉ Artificial Disc System DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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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. DePuy Spine Confidential. Do not Duplicate. Do not Distribute
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