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.The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar Stabilization™ is performed after decompression of stenosis at the affected level(s).
Based on the FDA clinical study, (Coflex is approved by FDA) when compared to the standard of care (fusion surgery), patients receiving the coflex® device experienced:
- Shorter operating time and hospital stay
- Quicker recovery
- Faster and sustained pain relief
- Greater mobility at treatment level
- Natural movement at adjacent levels
Benefits:
- Titanium alloy that is biocompatible and x-ray visible
- Crimping of wings for increased primary stability
- Five anatomical sizes
- Color-coded instrumentation
- Functionally Dynamic
- Compressible in extension, allowing flexion
- Increased rotational stability
- Center of rotation close to spinal canal
- Protection of Posterior Elements
- Stress reduction on facet joints
- Maintenance of foraminal height
- Large contact area for optimized stress distribution
- Ease of Use
- Less invasive, tissue-sparing procedure
- Easy and precise application
About Interspinous Devices
Interspinous spacers sometimes also called as Interspinous process decompression systems, are the devices implanted between vertebral spinous processes. These spacers are made up of a very strong but lightweight metal (titanium) which is biocompatible in the human body. These devices are imbedded in body to confine painful motion else enabling normal motion and to treat lumbar spinal stenosis, discogenic low-back pain, facet syndrome, disc herniations, and non-traumatic instability. Lumbar spinal stenosis is a thinning of the spinal canal in the lower back which causes compression on nerves and it is developed gradually with age. Radiology tests are used to confirm a diagnosis of moderate degenerative lumbar spinal stenosis. People with lumbar spinal stenosis experience pain but may also have weakness in their leg, lower back and buttocks, numbness, tingling.
The Interspinous spacer are implanted between those vertebrae in such a way that it prevents the patient from bending too far backward which causes pain by surgical procedure. The procedure is very small and sometimes patient can go home within a day.The increasing prevalence of spinal stenosis due to aging, arthritis, heredity and increased demand of surgical procedures that improved lifestyle and comfort will drive the Interspinous spacer market. The adoption of spacers are increasing due to low complication rate as compared to decompression and spinal fusion. The Interspinous spacers are widely used in geriatric population as per Medicare data due to old age patient are not comfortable with surgery due to their health conditions. Source:Transparency Market Research (TMR)
About Paradigm Spine (Surgalign)
Paradigm Spine, LLC was formed in 2005 to be a leader in the field of non-fusion spinal implant technology. The Company is committed to improving the quality of life of patients with spinal diseases through its mission: to provide products that are surgeon centric, indication specific, and data driven. Paradigm Spine is now an innovative leader in the global spine market and believes there is a significant opportunity to improve treatment options for patients suffering from lumbar spinal stenosis and age related spinal deformities.http://www.paradigmspine.com