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About this product

Division: Spine
Category: Minimally Invasive Surgery (MIS)

Turning MIS on its side with an integrated lateral platform.

The DePuy Synthes Spine MIS Lateral Platform leverages proven experience in designing products that treat a wide range of pathologies from the simple to the complex. This system was developed in close collaboration with top experts in the fields of neurosurgery and orthopaedic surgery to provide a comprehensive solution to meet your lateral needs.

The complete platform features the INSIGHT® Lateral Access System, PIPELINE® LS Lateral Access System, COUGAR® LS Lateral Cage System, and VIPER® 2 System. Neuromonitoring may be considered when performing a lateral surgical approach. This innovative, integrated platform of products provides controlled access, simplified cage insertion, and versatile posterior fixation options.

 

INSIGHT LS Lateral Access System Retractor | DePuy Synthes Companies INSIGHT Lateral Access System Retractor | DePuy Synthes Companies COUGAR LS Lateral Cage System | DePuy Synthes Companies PIPELINE LS Lateral Access System | DePuy Synthes Companies PIPELINE LS Lateral Access System | DePuy Synthes Companies
 

Indications for Use

INSIGHT Lateral Access System

INDICATIONS

The INSIGHT Lateral Access System is a modular and comprehensive retractor system designed to support the minimally invasive lateral approach to the thora-columbar spine. 

 

 

PIPELINE LS Lateral Access System

INDICATIONS

 

The PIPELINE LS Lateral Access System is intended for use with the COUGAR LS Lateral Cage System.


 

COUGAR® LS Lateral Cage System

INDICATIONS

 

The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine(i.e., T1 to 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. The 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 Synthes Spine supplemental internal fixation.

The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Synthes Spine supplemental internal fixation.
 

CONTRAINDICATIONS
 

  1. Use of this system is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.
  2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant.
  3. Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
  4. Prior fusion at the level to be treated is a contraindication for this system when used for intervertebral body fusion in spine.
  5. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure.
 

 

Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.

Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.

Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.

Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.
 

WARNING: This product has labeling limitations. See package insert for additional warnings, precautions and possible adverse effects.

CAUTION: USA law restricts this device to sale by or on the order of physician.


 

VIPER Spine System

INDICATIONS

 

The VIPER Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous, posterior approach with MIS Instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VIPER System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The VIPER System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
 

CONTRAINDICATIONS

Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.

Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.

Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.

Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.
 

WARNING: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.
 

PRECAUTION: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.

The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but must also be aware of the mechanical and metallurgical limitations of metallic surgical implants. Postoperative care is extremely important. The patient must be instructed in the limitations of the metallic implant and be warned regarding weight bearing and body stresses on the appliance prior to firm bone healing. The patient should be warned that noncompliance with postoperative instructions could lead to failure of the implant and possible need thereafter for additional surgery to remove the device.
 

WARNING: This product has labeling limitations. See package insert for additional warnings, precautions and possible adverse effects.

CAUTION: USA law restricts this device to sale by or on the order of physician.

 

Features & Benefits

INSIGHT LS Lateral Access System

  Features Benefits
MIS Lateral Platform retractor | DePuy Synthes Companies

Semi Radiolucent Retractor Components

Allow for controlled, distal expansion
Bifurcated Light Source Provide clear visibility in the working area
Low profile blade length and width extenders Allows for intraoperative blade depth adjustment to conform to anatomy and prevent muscle creep
Multiple fixation options including three strong arm attachment points and a posterior disc anchor blade Allows for expansion in the working area rather than at the skin level
Toeing capability Allows for visualization of cage placement
Eccentric dilators Provide flexibility to dilate in multiple directions; allows for repositioning of the dilators simply by rotating

PIPELINE® LS Lateral Access System

  Features Benefits
MIS Lateral Platform PIPELINE LS Lateral Cage System | DePuy Synthes Companies

Independent blades 

Allow for controlled, distal expansion
Innovative retractor blades Provide clear visibility in the working area
Telescoping feature Allows for intraoperative blade depth adjustment to conform to anatomy and prevent muscle creep
Toeing capability Allows for expansion in the working area rather than at the skin level
Top of retractor is radiolucent Allows for visualization of cage placement

COUGAR LS Lateral Cage System

  Features Benefits
MIS Lateral Platform COUGAR LS Lateral Cage System | DePuy Synthes Companies Self-distracting tip Allows for simplified cage insertion
Bulleted nose Facilitates streamlined insertion*
Pyramidal teeth Provide resistance to migration*
CFRP material Provides 2x strength of pure PEEK*
Radiolucent cage with full length tantalum wire markers  Allows visualization of cage placement

Versatility in Intraoperative Neuromonitoring

  Features Benefits
MIS Lateral Platform neuromonitoring | DePuy Synthes Companies

Proprietary neuromonitoring system is not required for use with the MIS Lateral Platform

Flexibility to choose the neuromonitoring equipment and staffing model which best meet your specific clinical and economic requirements

 

*Data on file with DePuy Synthes Spine.

DSUS/SPN/0316/1207 04/2016

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.
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