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The VertiFlex™ PEEK VBR is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaqed, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VertiFlex™ PEEK VBR 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. The interior of the VertiFlex™ PEEK VBR may be packed with bone graft.

The VertiFlex™ Octane™ PEEK Vertebral Body Replacement, or PEEK VBR, is an implant composed of pure Poly(Etheretherketone), or PEEK, intended to serve as a partial or total replacement of a vertebral body that is collapsed, damaged, or unstable as a result of tumor or trauma (i.e., fracture). The implant is available in a range of sizes, and is intended to achieve anterior decompression of the spinal cord and neural structures, and to restore vertebral height. In so doing, the device is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column. The device is hollow to permit packing with bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The device may be implanted by either conventional surgical methods, or via minimally-invasive techniques, using manual instrumentation provided by VertiFlex™, Inc., specifically for use with the subject device. The device is offered non-sterile.

When used as a posterior, noncervical pedicle screw system, the VertiFlex™ Spinal Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: - Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies; - Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; . - Degenerative spondylolisthesis; . - Trauma (i.e., fracture or dislocation); . - . Spinal stenosis; - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ● - Tumor: . - Pseudoarthrosis; and/or . - Failed previous fusion. .

The VertiFlex™ Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile.