The coflex ® Interlaminar Stabilization ® device is a non-fusion solution that effectively treats spinal stenosis of the low back. A single-piece titanium implant, the coflex Interlaminar Stabilization ® device goes in the back of the spine and treats moderate to severe cases of spinal stenosis. Here, we discuss a case of an FJC treated with both decompression and placement of a Coflex ILS device. Interlaminar implant. This is a minimally invasive alternative to more invasive laminectomy or laminectomy plus fusion surgery. As with many medical devices, the marketing challenges include building a case to physicians as well as to prospective patients. The coflex device offers an alternative to lumbar fusion after spinal decompression. The coflex® Interlaminar Technology is an Interlaminar Stabilization™ device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. This results in pain, numbness or weakness in the legs. Demonstrating the durability of positive outcomes is essential for validation of the appropriateness of ILS as a treatment option. Spinal fusion (such as a TLIF) is a surgical technique to stabilize the spinal vertebra and the disc or shock absorber between the vertebra. Coflex is an interlaminar stabilization device that treats lumbar spinal stenosis. To evaluate the safety and efficacy of Coflex interlaminar stabilization compared with posterior spinal fusion in the treatment of 1- and 2-level spinal stenosis and degenerative spondylolisthesis. Lumbar fusion surgery is designed to create solid bone between the adjoining vertebra, eliminating any movement between the bones. 470 patients were enrolled in an Investigational Device Exemption or IDE trial at 29 sites with a 24-month follow-up and annually thereafter through 60 months. Auerbach J, Davis R et al (2011) Direct decompression and Coflex (registered trademark) interlaminar stabilization compared with laminectomy and posterior spinal fusion with pedicle screw instrumentation for spinal stenosis with back pain or degenerative spondylolisthesis: 2-year results from the prospective, randomized, multicenter FDA IDE trial. It’s amazingly simple, very strong, and flexible enough to support your spine without having to fuse your bones together. The coflex® Interlaminar Stabilization® device is a single-piece titanium implant that goes in the back of your spine to treat moderate to severe spinal stenosis. The Coflex® (Paradigm Spine, LLC, New York, NY) interlaminar stabilization (ILS) implant is a novel titanium, U-shaped device which acts as a motion-preserving stabilizer and has proven to be a viable alternative to instrumental fusion. The Coflex implant is the innovative device used during Interlaminar Stabilization surgery after decompression treatment is performed for lumbar spinal stenosis. Interlaminar spacers are implanted midline between adjacent lamina and spinous processes to provide dynamic stabilization either following decompression surgery or as an alternative to decompression surgery. The coflex ® device is a non-fusion, motion preserving stabilization implant, that is FDA PMA approved for the treatment of Lumbar Spinal Stenosis, and can be used in conjunction with a decompression or used in lieu of a spinal fusion. The coflex interlaminar-interspinous implant (Paradigm Spine, LLC, New York, ... A biomechanical study of an interspinous stabilization spinal implant (Coflex) was carried out using eight human lumbar L4/L5 motion segments. Interlaminar stabilization after direct decompression is a non-fusion surgical option that can provide the additional stability over decompression alone without the … Coflex® Non-Fusion Interlaminar Stabilization™ The Coflex® device is a small, titanium implant that goes in the back of your spine to treat moderate to severe spinal stenosis. The goal of the surgery is to reduce pain and nerve irritation. Interlaminar spacers have 2 sets of wings that are placed around the inferior and superior spinous processes. The Vertiflex Procedure underwent one of the most rigorous studies on Lumbar Spinal Stenosis. Coflex surgery is a neurological procedure that implants a titanium alloy device, known as the Coflex Interlaminar Stabilization device, in the back of your spine to relieve pain or numbness in the back, legs, or buttocks from spinal stenosis. 41(3): 402-404. The Coflex® Interlaminar Stabilization Device is considered experimental / investigational and is not a covered benefitdue to a lack of research demonstrating efficacy for … Summary of Background Data. Currently, there is one product that has achieved FDA PMA approval for up to a Grade I spondylolisthesis, the coflex (Paradigm Spine, New York, NY). * *Claims based on US FDA PMA P110008, October 2012, and ESCADA data, published in Journal of Neurosurgery: Spine. coflex ® Coflex Interlaminar Stabilization: Non-fusion, motion preserving treatment for lumbar spinal stenosis. The coflex® Interlaminar Stabilization™ Device About Lumbar Spinal Stenosis Spinal stenosis is the gradual result of aging and "wear and tear" on the spine from everyday activities. What is coflex®? To learn more about coflex ® Interlaminar Stabilization ®, please visit www.coflexsolution.com. The device successfully implants between the two adjacent spinal bones immediately after the surgical relief of pressure on the spinal nerves. Regional Anesthesia and Pain Medicine 2016. Coflex surgery refers to a neurological procedure that implants a U-shaped, titanium alloy device, known as the “Coflex Interlaminar Stabilization Device”, in the lower back of the patient’s spine. • Page J, Moisi M, Oskouian RJ: Lumbar Epidural Hematoma Following Interlaminar Fluoroscopically Guided Epidural Steroid Injection. Coflex Interlaminar Stabilization Motion Preserving Minimally Invasive Treatment for Spinal Stenosis. The coflex Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. Spinal stenosis is a narrowing of the spinal canal, which places pressure on the spinal cord and nerves. coflex Interlaminar Stabilization Coflex Interlaminar Stabilization is a small device used in the treatment of lumbar spinal stenosis. * *Claims based on US FDA PMA P110008, October 2012, and ESCADA data, published in Journal of Neurosurgery: Spine. For patients, … Read More The Coflex device itself is a U … Interlaminar stabilization after direct decompression is a non-fusion surgical option that can provide the additional stability over decompression alone without the rigidity of an instrumented fusion. This wear and tear on the spine can lead to pressure on the nerves that may cause pain and/or damage. The coflex IDE clinical trial is the only level 1 study examining longer-term outcomes of interlaminar stabilization after direct surgical decompression for lumbar spinal stenosis. The coflex ® Interlaminar Stabilization ® device is a minimally invasive posterior lumbar motion preservation solution that addresses leg and back pain and has proven long-term outcomes for durable pain relief and stability. The coflex device is inserted after a microsurgical decompression and is for patients with moderate to severe leg pain caused by lumbar spinal stenosis who may or may notKnow More Volume 28 Issue 4, April 2018. Coflex interspinous process dynamic stabilization is effective in the long-term treatment of lumbar spinal stenosis, the ISH and IFH of implanted segment could be increased in a … Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial. coflex was developed by Paradigm Spine, LLC, and acquired by Alachua, Florida-based RTI Surgical, Inc. in March 2019. The coflex ® Interlaminar Stabilization ® device is a minimally invasive posterior lumbar motion preservation solution that addresses leg and back pain and has proven long-term outcomes for durable pain relief and stability. It is the only FDA-approved device offering non-fusion, motion preserving interlaminar stabilization. The coflex device is a small titanium implant that can help relieve the pain caused by spinal stenosis. Lumbar Forminotomy-Facetectomy Surgery relieves Leg, Arm, Back, and Face pain associated with the lower back by removing pressure on the nerves. It is a proven, non-fusion treatment option that fills the gap between decompression alone and decompression with fusion for patients with lumbar spinal stenosis […] Learn more here. The device is manufactured by Paradigm Spine and was approved for the treatment of certain … Coflex Interlaminar Stabilization Device This device allows for some stabilization in cases where decompression is needed, but there is a desire to avoid screws and a spinal fusion. Dr. Bae, a board-certified surgeon, is an expert in motion preservation fusion alternatives and is the leading investigator on two new devices approved by the FDA: the Mobi-C cervical disc replacement (Mobi-C) and the coflex Interlaminar Stabilization device (coflex). 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