What is Coflex® Interlaminar Stabilization® Device
In addition to decompression,neutralization with Coflex maintains the width of the spinal canal and the segment remains mobile.
Coflex is also intended to prevent adjacent level disease.
The Coflex device is a titanium implant used to stabilize the spine after a decompression surgery, specifically for lumbar spinal stenosis. It’s designed to be inserted between two adjacent vertebrae in the lower back, providing support and allowing the spine to retain its natural range of motion without needing a full spinal fusion.
How it works:
• The device is implanted after a decompression surgery, where bone, facet, ligament, and/or disc segments are removed to relieve pressure on the spinal nerves.
• The Coflex implant is placed between the two spinous processes (the bony protrusions at the back of the vertebrae).
• It’s designed to help unload the facet joints, restore the foraminal height (the space where nerve roots exit the spine), and provide stabilization.
• The device allows the spine to maintain its natural range of motion while providing support.
• It can be used as an alternative to spinal fusion for patients with lumbar spinal stenosis.
Benefits:
• May offer a less invasive alternative to traditional spinal fusion.
• Can help to alleviate pain caused by spinal stenosis by reducing pressure on the nerves.
• Allows for natural spine movement.
• May lead to faster recovery compared to spinal fusion.
Risks:
• Potential for infection, wound healing problems, or nerve damage.
• The device itself can sometimes cause issues, such as migration, fracture of the spinous processes, or the need for a removal surgery.
• Not all patients are suitable for the Coflex procedure, and there are contraindications such as prior fusion or severe facet hypertrophy
Why Coflex®?
The Coflex® Interlaminar Stabilization®Technology is an interlaminar functionally dynamic implant designed to impart a stabilization effect at the operative level(s) after a decompression surgery while retaining natural motion. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V, per ASTM F136 and ISO 5832-3). In clinical use, the “U” is positioned horizontally, with its apex oriented anteriorly and the two long arms of the “U” paralleling the long axis of the spinal processes. The implant bears load on interlaminar bone, and compresses upon spinal extension. The bone-facing surfaces are ridged to provide resistance to migration.
The Coflex® device is an alternative to fusion for a subset of lumbar spinal stenosis patients
The Coflex® device is an option for those in the “decision zone” between decompression alone and fusion procedures. It is for patients that experience moderate to severe stenosis, have an ODI greater than 40 as well as a back-pain VAS score greater than 50. It is ideal for patients who have up to stable grade I spondylolisthesis. When combined with decompression, it is strong enough to support the patient’s spine for longer, but flexible enough to allow for maximum movement. It also requires minimal equipment, has a shorter recovery time, and yields effective results over time.
The design and location of the device in the patient’s back helps to maintain foraminal height and off-loads facets to reduce leg and back pain.
What does the Coflex®device offer your patients?
The Coflex® device is the exclusive posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability. It is an option for patients that do not want to go through pedicle screw fusion, but a decompression alone would not offer needed stability.
Coflex® device benefits:
• Stabilization of the segment
• Motion preservation (constrained)
• Off-loading of the facet joints and discs
• Less invasive: reduced surgical time, blood loss, and length of stay1
The Coflex® Device Has Been Implanted More Than 175,000 Times in Over 60 Countries, by Over 1,500 Spine Surgeons
