The Fusion of Power and Performance.

Transcription

1 The Fusion of Power and Performance.

2 Leading the Way in Lumbar Interbody Fusion with 1 Years of Clinical Results. The JAGUAR Lumbar I/F CAGE System, approved in the U.S. in February 1999, has revolutionized interbody fusion treatments by providing surgeons with the first radiolucent interbody device to allow for accurate post-operative fusion assessment. Since that time, more than 25, patients have benefited from the JAGUAR product line. The only system with documented 1-year clinical results 1, it has been proven to achieve fusion rates at or above 9%, and restore and maintain disc heights 2. Large Cranial/Caudal Openings Allow the maximum area for bone graft inside the cage and the most surface area for bone graft-to-endplate contact. Tantalum Marker Beads Visualization of implant is achieved by tantalum marker beads. Surface Teeth Help to resist implant migration in the disc space. Continuous Lateral Openings Provide for vascularization throughout the cage to enhance fusion.

3 Confidence with a Proven History of Achieving Normal Sagittal Plane Alignment JAGUAR cages are available in º, 5º and 1º of lordosis allowing the surgeon to achieve proper sagittal plane alignment. A prospective, multi-center IDE clinical study was conducted to evaluate the safety and effectiveness of the JAGUAR System in patients with Degenerative Disc Disease (DDD) 1 5º 1º In a clinical study of the JAGUAR Wedged I/F CAGE, post-operative L4-S1 sagittal alignment averaged 3.4º and fell within the range of normal values previously reported in the literature 3. A published report by Jackson and McManus reported that distal lordosis averaged 41 +/- 11.2º in normal volunteers and 36 +/- 12.8º in patients with low back pain 4. CLINICAL SUCCESS The JAGUAR System yielded excellent clinical results. Patient satisfaction was 86% at 24 months, as judged by the patient. Pain Improvement 1 Percent 5 Unparalleled Clinical Success Rate at Ten-Year Patient Follow-Up 1 Thirty-three patients treated with the JAGUAR cage as part of the IDE study, had an average post surgical follow-up of months. The high rate of clinical and fusion success demonstrated in these patients at 24 months was maintained at ten-year follow-up. 12 mos 24 mos Functional Success 1 1% 95% 9% 85% 8% 86.5% 1% 87.8% 96.7% Clinical Success Fusion Success Percent 5 75% 24 mos 1 yrs Patient success rate using the JAGUAR System at 24 months and 1 years. (One patient judged fused at 24 months was reported as a fusion failure at 1 years). 12 mos 24 mos

4 Performance. DISC HEIGHT MAINTENANCE Clinical study data shows that the JAGUAR System effectively maintains disc height over time Millimeters 5 Preop Postop 3 mos 6 mos 12 mos 24 mos Patient disc height is restored and maintained 24 months post surgery with the JAGUAR cage. FUSION SUCCESS The JAGUAR System demonstrated high fusion rates (9%) at 24 months, while adhering to a strict definition of fusion. At a minimum, the patient had to demonstrate increased density of the fusion mass from one x-ray interval to the next. In this scale, the 1% of patients who were graded as a pseudoarthrosis demonstrated bone bridging the fusion area with no lucencies at 24 months. 1 Percent 5 12 mos 24 mos Continuous Trabecular Bone Increased Density of Fusion Bone Bridging Fusion Area Fusion results 12 months and 24 months following surgery with the JAGUAR cage.

5 They lie undetected in their environment Powerful teeth ready to grip any surface Sleek, strong bodies agile enough to conquer any terrain DePuy Spine introduces the Big Cats, a family of spinal fusion implants made of Carbon Fiber Reinforced Polymer, the premier fusion enabling material to reconstruct the anterior column of the spine. STRENGTH 2% greater than pure PEEK 5 OPEN DESIGN Maximum area for bone graft and lateral vascularization PROVEN CLINICAL SUCCESS CFRP implants have over a decade of use in the spine 1 RADIOLUCENCY Accurate fusion assessment CFRP. Unleash the Power & Performance

6 I N D I C A T I O N S The JAGUAR Lumbar I/F CAGE is indicated for an open posterior approach, using autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion, combined with posterolateral fusion (36 fusion) and posterior pedicle screw fixation. The JAGUAR Lumbar Wedged I/F CAGE is indicated for an open posterior approach, using autologous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L4- S1 whose condition requires the use of interbody fusion, combined with posterolateral fusion (36 fusion) and posterior pedicle fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). More than 25, patients treated. Interbody fusion success of 9% or greater. The only interbody system with documented 1-year clinical success. Lordotic cage design proven to restore normal sagittal plane alignment. CFRP. Unleash the Power & Performance DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Notice: There are labeling limitations for the use of the JAGUAR Lumbar I/F CAGE System. See the package insert supplied with this device for important information. LIMITED WARRANTY AND DISCLAIMER: DePuy Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please see the current price list for important warranty information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. DePuy Spine is a joint venture with Biedermann Motech GmbH. DEPUY SPINE TM, I/F CAGE, and JAGUAR TM are trademarks of DePuy Spine, Inc. 23 DePuy Spine, Inc. All rights reserved. To order, call DePuy Spine Customer Service ( ). 1. Brantigan, J.W., Neidre A., The Lumbar I/F Cage for PLIF with VSP Pedical Screw System - Ten Year Results of a Food and Drug Administration Clinical Trial. Presented at 18th Annual Meeting of National Association of Spine Surgeons, October 21-25, Brantigan, J.W., Steffee, A.D., Lewis, M., Quinn, L., Persenair, M., Lumbar Interbody Fusion using the Brantigan I/F Cage System for PLIF and the VSP Pedical Screw System: Two Year Clinical Results of the Food and Drug Administration Investigation Device Exemption. SPINE, Volume 25, 2 3. Brantigan, J.W., Neidre, A., Achievement of Normal Sagittal Plane Alignment using a Wedged Carbon Fiber Reinforced Polymer Fusion Cage in Treatment of Spondylolisthesis. The Spine Journal 3 (23) Jackson R.P, McManus A.C., Radiographic Analysis of Sagittal Plane Alignment and Balance in Standing Volunteers and Patients with Low Back Pain Matched for Age, Sex and Size. SPINE, 19: , Williams, DF., McNamara, A., Turner, RM. Potential of polyetheretherketone (PEEK) and carbon fiber-reinforced PEEK in medical applications. Journal of Material Science Letters: 6, 1987; DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 2767 IF1-2- 1/3 JC/QP