DePuy Spine Confidential. Do not Duplicate. Do not Distribute The CHARITÉ™ Artificial Disc...

DePuy Spine Confidential. Do not Duplicate. Do not Distribute

The CHARITÉ™ Artificial Disc

• World’s 1st commercially available artificial disc

• Motion preserving technology for treating select patients with Degenerative Disc Disease (DDD)

Timeline

— 1st prototype,SB CHARITÉ I(13 Patients)

— 2nd prototype,SB CHARITÉ II(37 Patients)

— SB CHARITÉ IIIAvailable in Europe

— J.P. Lemaire,M.D. Study 100 PatientsMin 10 Year Follow-up

—T. David, M.D. Study96 PatientsMin 5 Year Follow-up

—U.S. IDEClinical StudyFirst Implantation

—CENTRELINE™InstrumentsLaunched

—FDA ApprovalCENTRELINETM TDR Instruments Launched

1984

1985

1987

1989

1994

2000

2003

2004


Mobile-Core Design Translates to the Natural Choice


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


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


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.


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 CoreMoumene M, Geisler FH. “Effect of Artificial Disc Placement on Facet Loading: Unconstrained Vs. Semi-constrained.” Presented at the 4th AnnualMeeting of the Spine Arthroplasty Society, May 5, 2004.


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):271-85.

Unprecedented Clinical Results

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

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.

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

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 2 yr

> -15 pt 64% 58%

-15 to -10 pt 14% 9%

Total ≧ -10 pt 78% 67%

Maintained Motion

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

Maintained Disc Height

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

Patient Satisfaction

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

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

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 diseaseLemaire 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):271-85.

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.


Remarkable Durability


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


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

CHARITÉ

Fixed Core

3Mpa

24Mpa

Moumene M, Geisler FH. “Effect of Artificial Disc Placement on Facet Loading: Unconstrained Vs. Semi-constrained.” Presented at the 4th AnnualMeeting of the Spine Arthroplasty Society, May 5, 2004.


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:748-51.

Data on file


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):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.


Refined Surgical Procedure


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


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


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


CENTRELINE™ TDR Instrumentation

• New CENTRELINE™ TDR Instrumentation aids in

– consistent and accurate sizing and midline placement for optimal performance

• Six Steps of Implantation


6 Steps of ImplantationStep 1 Trialing

• Confirm footprint size (2-5) using the Sizing Gauges

• Confirm lordotic angle with the radiolucent Trials

• Verify proper placementMaximize endplate coverage


Step 2 Midline Identification

• Place Midline Marker using the Marker Inserter


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


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


Step 5 Core Trial and Insertion

• Confirm proper height with the Core Trials

• Insert Sliding Core with the Core Insertion Instrument


Step 6 Final Positioning

• Verify proper positioning in the AP and lateral planes


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


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


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


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 The CHARITÉ™ Artificial Disc...

Documents

Transcript of DePuy Spine Confidential. Do not Duplicate. Do not Distribute The CHARITÉ™ Artificial Disc...