Focus of the Report: The focus of this health technology assessment is use of the coflex Interlaminar Stabilization device (Surgalign Spine Technologies Inc.) for the treatment of lumbar spinal stenosis (LSS) in adults. The coflex device offers a minimally invasive adjunct to traditional decompressive surgery and a surgical alternative to spinal fusion.
Technology Description: The coflex device is a U-shaped implant manufactured from a medical-grade titanium alloy that is designed to withstand a normal physiologic load in the spine. The device is a single-piece design with 2 pairs of serrated wings: 1 pair extending from the upper long arm and the other pair extending from the lower long arm of the U. This design allows a simple press-fit insertion of the device. The U portion is positioned horizontally between 2 adjacent spinous processes and pressed into place. The wings are then crimped over the bone to hold the implant in place. Implantation is performed after decompression of stenosis at the affected level(s).
Controversy: Adverse sequelae associated with spinal fusion include symptomatic disease in adjacent spinal segments, increased morbidity, pseudarthrosis, and subsequent surgical reinterventions. As a result, less invasive motion-preserving alternatives to spinal fusion, such as the coflex device, have been developed and are under investigation.
Key Questions:
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Is use of the coflex Interlaminar Stabilization device following decompression effective in treating lumbar spinal stenosis (LSS) in skeletally mature patients with or without low-grade spondylolisthesis?
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How does use of the coflex Interlaminar Stabilization device following decompression compare with standard care of decompression with fusion or decompression only?
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Is use of the coflex Interlaminar Stabilization device safe?
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Have definitive patient selection criteria been identified for use of the coflex Interlaminar Stabilization device?
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