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DESCRIPTIONSurgical intervention for back pain is usually reserved for people with chronic back pain for which other treatments have failed. Surgery may be required for people who have chronic low back pain and sciatica (often diagnosed with a herniated disc), spinal stenosis, spondylolisthesis (vertebra of the lumbar spine slips out of place), or vertebral fractures with nerve involvement. In addition, surgery may be needed for people with discogenic low back pain (degenerative disc disease), which occurs with the aging process. The surgical intervention most commonly used to treat non-cervical spinal abnormalities is spinal fusion. In spinal fusion, two or more vertebrae are joined together to immobilize the spine by using bone grafts, screws, and rods to stop slippage of the affected vertebrae.
The CD HORIZON® Spinal System is made up of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. The system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
One device for non-pedicle supplemental fixation in the non-cervical spine is the modified CD HORIZON® Spire Spinal System (Medtronic Sofamor Danek, Memphis,TN). It was cleared by the Food and Drug Administration (FDA) in October 2004 through the 510(k) process as a part of the CD HORIZON® Spinal System. The device was judged to be substantially equivalent to the predicate SPIRE plates previously cleared in September 2003. The device is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1). It allows surgeons to fixate the spine by attaching a plate to the spinous process of the vertebrae body during spinal fusion surgery without the use of fluoroscopy. The device may also be used as a supplement to the CD HORIZON® Rod and Screw System or as supplemental fixation with existing CD HORIZON® Spinal System products when surgeons perform a Minimal Access Spinal Technology Transforaminal Lumbar Interbody Fusion (TLIF). The intended use as listed on the 510(k) approval from 2004 (#K043053) is for the following conditions: degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, and/or tumor.
Patients undergoing a SPIRE plate implantation receive an intraoperative lateral lumbar spine x-ray film in order to locate the target level. Intraoperative fluoroscopy is not required for the implantation. An incision is made over the spinous process at the target level. After subcutaneous fat and fascia are divided and retracted, electrocautery is done for a subperiosteal dissection. At the target level, the interspinous ligament is removed, and the supraspinous ligament is left intact to facilitate anatomical closure. Portions of the laminae and/or spinous process may also be harvested for autograft and placed into the laminar and/or interspinous space for posterior arthrodesis prior to implantation of the plate.
The SPIRE plate consists of two titanium plates with opposing spikes that are connected at the midpoint by a polyaxial stem. The SPIRE plate is available in two sizes: 45 mm in length with a width of 12mm, and a thickness of 3mm; or 35 mm in length, with the other dimensions remaining the same. The plate is inserted so that the rostral and caudal portions of each blade make contact with their targeted spinous processes and conform to the anatomy. Once the plates are in an optimal position, a compression instrument is used to clamp the plates toward each other, driving the spikes into the bone. During compression, a locking screw is inserted and tightened, and a rigid fixation is achieved.
A non-pedicle supplemental fixation device for use in the non-cervical spine in conjunction with minimally invasive surgery on the spine is a new and evolving technique. The potential benefits of this type of surgery include shorter operative time, less post-operative estimated blood loss, and shorter hospital stays. Early published results show that the technique is relatively feasible and safe; however, the data is insufficient to permit conclusions as to whether the technique improves health outcomes.
Non-pedicle supplemental fixation devices for use in the non-cervical spine are considered investigational.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
7/19/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
7/23/2007: Policy added
SOURCE(S)CD Horizon spinal system summary of safety and effectiveness October 2004. Accessed April 2, 2007. Available at: http://www.fda.gov/cdrh/pdf4/K043053.pdf.
Wang JC, Haid RW, Miller JS, Robinson JC. Comparison of CD HORIZON SPIRE spinous process plate stabilization and pedicle screw fixation after anterior lumbar interbody fusion. J Neurosurg Spine. 2006; 4: 132-136.
Wang JC, Spenciner D, Robinson JC. SPIRE spinous process stabilization plate; biomechanical evaluation of a novel technology. J Neurosurg Spine. 2006; 4: 160-164.
CODE REFERENCEAll codes billed are considered investigational and not eligible for coverage.