Coflex F stabilization system is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (LI – SI).
It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies with up to Grade I spondylolisthesis. The minimally invasive system is designed to allow for a low-profile, tissue-friendly, anatomical fit.
Design Features:
- Interlaminar positioning
- Secure anchorage through rivet fixation
- Large contact area for optimized stress distribution
- Five anatomical sizes
- Color-coded instrumentation
- Titanium alloy that is biocompatible
- Reduced Iatrogenic Trauma
- Less muscle trauma and blood loss
- Smaller skin incision
- Reduced Surgical Risks
- Excellent safety profile
- Protection of neural structures
- Reduced Cost
- Shorter operating time
- Faster patient rehabilitation
- Ease of Use
- Simple surgical technique
- Intuitive instrumentation
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