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VIPER®2 Minimally Invasive Pedicle Screw System

  • category: Minimally Invasive Surgery (MIS)
  • product family: VIPER® MIS Spine System

The VIPER® 2 System is the evolution of minimally invasive spine surgery. Building upon the groundbreaking design and intuitive techniques established by the original VIPER System, the VIPER 2 System empowers Spine Surgeons to treat an unparalleled range of pathologies with a single platform solution.

By delivering a comprehensive range of instrumentation and implant options, the VIPER 2 System provides surgeons with the confidence and control required to address more complex cases with a less invasive approach.

Born from the EXPEDIUM® Spine System and evolved from the original VIPER System, the VIPER 2 System takes percutaneous fixation to the next level.

 

VIPER® MIS Spine System

Scoliotic C

MIS Logo Adaptable MIS solutions for an evolving practice

 

MIS DEGENERATIVE

A Faster, Simpler Approach to Percutaneous Degenerative Fixation

· Streamlined Rod Placement
· Minimal Muscle Trauma
· Simple Percutaneous Reduction
  Options

MIS Degenerative

 

MIS DEFORMITY

The Confidence to Treat Deformity with an MIS Approach

· Versatile & Secure Correction
  Solutions
· Powerful Internal Approximation
  Options
· Low-Profile Instrument Design

MIS Deformity

 

MIS TRAUMA

Versatility for the Demands of MIS Trauma Stabilization

· Streamlined Percutaneous Rod
  Placement
· Simple Reduction Options
· Flexibility to Deliver Any   Curvature Rod

MIS Trauma

 

MIS TUMOR

Streamlined MIS Posterior Fixation for Tumor Surgery

· Versatility to Instrument the
  Entire Thoracolumbar Spine
· Percutaneous Revision Options
· Elegance of the X-Tab Screw
  Design

MIS Tumor

 

Please refer to the Features and Benefits section for more information.

Indications
The VIPER® 2 Spine Systems are 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 2 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 posterior percutaneous approach with MIS instrumentation, the VIPER2 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 2 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The VIPER 2 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.
 

 

CA #8566
CA#8477

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Apr 14 2014 - 14:07:52