coflex® Interlaminar Stabilization™

coflex

The First and Only Motion Preserving Minimally Invasive Treatment Approved for Moderate to Severe Spinal Stenosis After 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. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 adjacent lumbar motion segments. The Interlaminar Stabilization™ device is implanted after decompression of stenosis at the affected level(s).

Based on the FDA clinical study that has been published with 5 year follow-up data, 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

The coflex® Interlaminar Technology Design

The coflex® device consists of a single, U-shaped component, made from medical-grade titanium alloy, a material with a long history of safe use in implantable orthopedic products. 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 spinous processes. The bone-facing surfaces are ridged to provide resistance to migration.

coflex® Features

  • 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
  • Less invasive, tissue-sparing procedure
  • Easy and precise application
6020 W. Parker Road, Suite 200
Plano, TX
75093 United States
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