Category: Minimally Invasive Surgery (MIS)
The VIPER® 2 System is a single platform solution with a comprehensive range of instrumentation and implant options. The VIPER 2 System provides surgeons with the confidence and control required to address a wide range of spinal pathologies, including the more advanced indications while maintaining a less invasive approach. The VIPER 2 System makes degenerative MIS cases easier and complex MIS cases possible with a single versatile system.
Why MIS? Minimally invasive approaches have been shown to typically reduce complications, overall costs, pain, infection rates, and blood loss and yield quicker recovery than traditional open surgery.
The EXPEDIUM Spine System and VIPER 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 EXPEDIUM Spine System and VIPER Systems 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior approach with MIS Instrumentation, the VIPER Systems 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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.
|Two-step extension loading||Provides ease of use
May streamline surgical technique to increase operating room efficiency
|Low-profile extensions and rod holders||Minimizes incision size and crowding in lower lumbar spine
Reduces trauma to patient; no unnecessary additional incisions for rod insertion
|Secure rod and screw extensions||Provides intraoperative adaptability
Provides ability to treat multi-level procedures
Allows for basic vertebral body manipulation and reconstruction
|More than 30 comprehensive instruments||Designed to handle multiple pathologies, from degenerative to deformity|