Risks Along with the benefits of this technology, there are also potential risks. Risks associated with the Aspen™ device include, but are not limited to: • Early or late implant bending, breakage, failure, loosening or movement/migration • Bone and/or spinous process fracture • Allergic reaction to implant material Preoperative diagnostic evaluation followed by carefully executed surgical technique is required. Postoperative care, individualized to suit the particular injury/disease requirements, is essential for optimum outcome. The surgeon must be fully aware of the risks and complications inherent to this type of surgery. Only those individuals with specialized training and experience in spinal surgery should attempt use of the implants. Patient selection is extremely important. Refer to the Instruction for Use (IFU) for a more complete description of indications, contraindications, warnings, cautions and other information about the system.
Patient Assessment The Aspen device is indicated for use in skeletally mature patients requiring arthrodesis for degenerative disc disease, spondylolisthesis, trauma and/or tumor at the T1-S1 levels. The ideal patient for arthrodesis would have failed at least 3 months of conservative therapy including physical therapy, exercise, and/or analgesics and have documented confirmation of medical necessity for fusion. Lumbar fusion is often deemed medically necessary when there is associated spinal instability, spinal stenosis with associated spondylolisthesis, spondylolysis, chronic unremitting pain with function impairment, recurrent disc herniation, adjacent segment degeneration, and/or pseudarthrosis. As the Aspen device fixates the spinal segments by driving spikes into the cortical bone of the adjacent level spinous processes and laminar bone, the device is contraindicated when there is an incompetent or missing posterior arch.
Surgical Approach Lumbar fusion may be performed using various surgical techniques and instrumentation. Surgical approaches used to perform spinal fusion include anterior, posterior, and lateral. It is well accepted that anterior lumbar interbody fusion, posterior lumbar interbody fusion, transforaminal lumbar interbody fusion and posterolateral fusion are standard approaches to performing spinal fusion. When deviating from standard spinal fusion approaches, procedures may be viewed as experimental, investigational or unproven. The Aspen device is part of the Lanx Spinal Fixation System which offers the surgeon a variety of implant components from which to assemble a suitable construct according to each individual patient’s needs and requirements. Like pedicle screws, facet screws, hooks, and rods, the Aspen device is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. Standard approaches to performing spinal fusion are required when utilizing the Aspen device.
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