The Fusion of. Strength, Design. Performance. and
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1 The Fusion of Strength, Design and Performance Interbody Fusion Platform
2 Interbody Fusion Platform The DePuy Spine Interbody Fusion platform is designed to provide an open architecture implant in a load-sharing environment. The strength, design and performance of these implants and the variety within the portfolio gives you a choice of powerful options for your cervical and lumbar degenerative pathologies. Self-distracting implants and instruments for simplified cage insertion Bulleted nose facilitates easier insertion* Designed to address collapsed disc spaces Pyramidal teeth designed for higher resistance to migration* Patented lordotic design for sagittal balance in the oblique position 33% more bone graft area* Appropriate for both open and MIS TLIF approaches * vs. competition. Data on file. TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) Anatomical fit for balanced anterior column support LEOPARD Contoured caudal and rostral surfaces conform to the anatomy Open architecture designed for load-sharing in implant Mid-line I-Beam increases construct strength
3 Interbody Fusion Platform The DePuy Spine Interbody Fusion platform is designed to provide an open architecture implant in a load-sharing environment. The strength, design and performance of these implants and the variety within the portfolio gives you a choice of powerful options for your cervical and lumbar degenerative pathologies. TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) Self-distracting implants and instruments for simplified cage insertion Bulleted nose facilitates easier insertion* Designed to address collapsed disc spaces Pyramidal teeth designed for higher resistance to migration* Patented lordotic design for sagittal balance in the oblique position 33% more bone graft area* Appropriate for both open and MIS TLIF approaches * vs. competition. Data on file. Anatomical fit for balanced anterior column support LEOPARD Contoured caudal and rostral surfaces conform to the anatomy Open architecture designed for load-sharing in implant Mid-line I-Beam increases construct strength
4 ALIF (ANTERIOR LUMBAR INTERBODY FUSION) Innovative self-distracting inserter for smooth and controlled cage insertion Inserter combines disc space distraction and insertion into a single step Large openings provide surface area for bone graft-to-endplate contact Multiple threaded insertion holes for surgical approach flexibility Chamfered edges designed for easy insertion Surface teeth designed to resist implant migration and/or retropulsion Large footprint offers optimal endplate coverage for maximum stability COUGAR PLIF (POSTERIOR LUMBAR INTERBODY FUSION) Contoured profile for anatomical fit Contoured profile to fit the natural shape of disc space, allowing implant to correspond with cortical rim of endplate Multiple insertion holes allow for anterior or posterior approach SABER
5 ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) Open architecture to maximize graft volume Open design allows for bone graft-to-endplate contact Anatomical shape designed to fit naturally in the cervical spine Simple and effective instrumentation for preparation and insertion BENGAL Cervical Interbody System
6 OPEN ARCHITECTURE DESIGN IN A LOAD-SHARING ENVIRONMENT The DePuy Spine family of interbody spinal fusion implants are made of carbon fiber reinforced polymer (CRFP) - a premier material. Composed of 30% carbon fiber and 70% PEEK, CFRP has a strength that allows for optimal cage design resulting in an implant that meets the structural requirements of anterior column support, while optimizing the fusion environment through an open, load-sharing construct. Strength Strong enough to withstand in vivo loads with an optimized stiffness for load-sharing Open design Maximized area for bone graft, lateral vascularization, and load-sharing Proven Clinical Success CFRP implants have over a decade of use in the spine
7 Interbody Fusion Platform Also available from DePuy Spine through distribution agreement with LifeNet Health, the Vertigraft Allograft Bio-Implant products. Self-distracting implants and instruments for simplified cage insertion LEOPARD Anatomical fit for balanced anterior column support VG2 Cervical Allograft COUGAR Innovative self-distracting inserter for smooth and controlled cage insertion VG1 ALIF Allograft SABER Contoured profile for anatomical fit VG2 PLIF Allograft BENGAL Cervical Interbody System Open architecture for maximum graft volume VG2 TLIF Allograft INDICATIONS CONCORDE, COUGAR and LEOPARD Systems The CONCORDE, COUGAR and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE), TLIF (CONCORDE, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation. The CONCORDE, COUGAR and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation. BENGAL System The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation may be used. The BENGAL System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation. SABER System The SABER Lumbar I/F CAGE System 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 (360 fusion) and posterior pedicle screw fixation. The Wedged SABER 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 levels from L4-S1 whose condition requires the use of interbody fusion, combined with posterolateral fusion (360 fusion) and posterior pedicle fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). 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 SABER 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. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. DEPUY SPINE and the DePuy Spine logo are trademarks of DePuy Spine, Inc. BENGAL, CONCORDE, COUGAR, LEOPARD, SABER, VG1 and VG2 are registered trademarks of DePuy Spine, Inc. Not all products are currently available in all markets DePuy Spine, Inc. All rights reserved. To order, call DePuy Spine Customer Service ( ). DePuy Spine, Inc. 325 Paramount Drive Raynham, MA USA Tel: +1 (800) IF /09 JC/RPI
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