Coflex® approved by the FDA! In October, 2012, Paradigm Spine LLC was granted a premarket approval (PMA) order from the FDA for coflex®, a minimally invasive, motion preserving interlaminar stabilization device for the treatment of moderate to severe spinal stenosis with or without back pain.
The investigational device exemption (IDE) study, in which the Spine Institute participated, demonstrated that:
The coflex® is implanted in the interlaminar (between the vertebrae) space following decompression surgery to provide stability in the spinal column. If you have moderate to severe spinal stenosis and would be interested in learning more about spine stabilization without fusion, please contact us, and we can tell you more about coflex®.
To treat back pain in some cases, a lumbar spinal fusion using a bone graft is created to stop motion at a painful vertebral segment. When the motion stops, the pain should stop as well.
While the bone graft fuses, the coflex-F® implant provides support to the spine, improving the fusion success rate. The implant is solidly connected to the spinous processes on the vertebrae involved in the fusion to stabilize the spine in a similar manner to pedicle screws that are traditionally used, but without the complications.
Patients who would be good candidates for the coflex-F implant are those whose doctors recommend an interbody, single-level lumbar spine fusion as a treatment for degenerative disc disease and up to grade 1 spondylolisthesis.
Implanting the coflex-F device is a minimally invasive procedure performed after the implantation of an interbody cage, which houses the bone graft material. The benefits of the coflex-F include:
View this PDF for more information on the coflex-F® implant.
The coflex-F implant is an FDA-approved device. For a consultation on whether the device is suitable for your situation, please contact us.
Visit the Paradigm Spine website for more information on the coflex implants.
These are investigational devices and are currently not available in the US.
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