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VIPER® 3D MIS Correction Set

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

The VIPER® 3D MIS Correction Set is the world’s first minimally invasive deformity system that allows the surgeon to treat the entire thoracolumbar spine minimally invasively. This system is used in conjunction with the VIPER 2 MIS Spine System to bring the benefits of minimally invasive surgery to more patients by providing innovative instrumentation designed specifically to treat complex pathologies.

Fully compatible with the EXPEDIUM® Spine System implants and instruments, the VIPER 3D Set enhances surgeons’ abilities to treat complex pathologies through a variety of techniques and approaches. The VIPER 3D instrumentation is designed to allow complex surgery to be done percutaneously.

The VIPER 3D Set features specialized instruments for easy multi-level rod insertion with 360° rod rotation, powerful rod approximation, segmental or en bloc de-rotation, spondy reduction, controlled multi-level compression & distraction, and the ability to perform posterior-lateral fusion minimally invasively.

Adaptable MIS solutions for an evolving practice.

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, pseudarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System are 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, pseudarthrosis; and failed previous fusion in skeletally mature patients.

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 #8478
CA #8566

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Apr 14 2014 - 14:07:52