Lumbar fusion surgery is designed to create solid bone between the adjoining vertebra, eliminating any movement between the bones. 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 The Vertiflex Procedure underwent one of the most rigorous studies on Lumbar Spinal Stenosis. 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. 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’s amazingly simple, very strong, and flexible enough to support your spine without having to fuse your bones together. The goal of the surgery is to reduce pain and nerve irritation. Summary of Background Data. Interlaminar stabilization after direct decompression is a non-fusion surgical option that can provide the additional stability over decompression alone without the … • Page J, Moisi M, Oskouian RJ: Lumbar Epidural Hematoma Following Interlaminar Fluoroscopically Guided Epidural Steroid Injection. The Coflex implant is the innovative device used during Interlaminar Stabilization surgery after decompression treatment is performed for lumbar spinal stenosis. 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. Demonstrating the durability of positive outcomes is essential for validation of the appropriateness of ILS as a treatment option. 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. The Coflex® Interlaminar Stabilization Device is considered experimental / investigational and is not a covered benefitdue to a lack of research demonstrating efficacy for … 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). 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). 41(3): 402-404. Spinal stenosis is a narrowing of the spinal canal, which places pressure on the spinal cord and nerves. Spinal fusion (such as a TLIF) is a surgical technique to stabilize the spinal vertebra and the disc or shock absorber between the vertebra. This is a minimally invasive alternative to more invasive laminectomy or laminectomy plus fusion surgery. coflex Interlaminar Stabilization Coflex Interlaminar Stabilization is a small device used in the treatment of lumbar spinal stenosis. The Coflex device itself is a U … Learn more here. This results in pain, numbness or weakness in the legs. The device successfully implants between the two adjacent spinal bones immediately after the surgical relief of pressure on the spinal nerves. The coflex ® Interlaminar Stabilization ® device is a non-fusion solution that effectively treats spinal stenosis of the low back. This wear and tear on the spine can lead to pressure on the nerves that may cause pain and/or damage. 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. 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. 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. It is the only FDA-approved device offering non-fusion, motion preserving interlaminar stabilization. To learn more about coflex ® Interlaminar Stabilization ®, please visit www.coflexsolution.com. What is coflex®? 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 device offers an alternative to lumbar fusion after spinal decompression. For patients, … Read More 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. Lumbar Forminotomy-Facetectomy Surgery relieves Leg, Arm, Back, and Face pain associated with the lower back by removing pressure on the nerves. 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. 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. * *Claims based on US FDA PMA P110008, October 2012, and ESCADA data, published in Journal of Neurosurgery: Spine. 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 […] 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 … Interlaminar implant. Coflex is an interlaminar stabilization device that treats lumbar spinal stenosis. As with many medical devices, the marketing challenges include building a case to physicians as well as to prospective patients. Here, we discuss a case of an FJC treated with both decompression and placement of a Coflex ILS device. 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. 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. 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. Regional Anesthesia and Pain Medicine 2016. * *Claims based on US FDA PMA P110008, October 2012, and ESCADA data, published in Journal of Neurosurgery: Spine. 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. 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. 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 ® Coflex Interlaminar Stabilization: Non-fusion, motion preserving treatment 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 a small titanium implant that can help relieve the pain caused by spinal stenosis. coflex was developed by Paradigm Spine, LLC, and acquired by Alachua, Florida-based RTI Surgical, Inc. in March 2019. Interlaminar spacers have 2 sets of wings that are placed around the inferior and superior spinous processes. The device is manufactured by Paradigm Spine and was approved for the treatment of certain … 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. 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. Volume 28 Issue 4, April 2018. 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. To reduce pain and nerve irritation RJ: lumbar Epidural Hematoma Following Interlaminar Fluoroscopically Guided Steroid... The coflex device offers an alternative to lumbar fusion surgery decompression and placement of a ILS. 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