coflex® Interlaminar Stabilization™

The 1ST 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 contiguous lumbar motion segments. Interlaminar Stabilization™ is performed after decompression of stenosis at the affected level(s).  Please see Instructions for Use for complete list of warnings, precautions and contraindications.

A brief overview of information related to FDA’s approval to market coflex®, as well as links to the Summary of Safety and Effectiveness Data (SSED) and product labeling can be accessed by visiting the following link:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm327502.htm

Based on the FDA clinical study, 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
 
Click here to learn more about coflex® clinical data

coflex® Procedural Video

 

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

Ease of Use

  • Less invasive, tissue-sparing procedure
  • Easy and precise application
 

 

For more information on this technology, please review the materials for download below:

coflex® Brochure - coflex® Brochure.pdf

coflex® Patient Education Pamphlet - coflex® Patient Education Pamphlet.pdf

coflex® Instructions for Use - coflex® Instructions for Use.pdf

coflex® RRY Publications Article - RRY The Right Trial - coflex®.pdf

 

For Customer Service inquiries, contact customerservice@paradigmspine.com or 917.388.6139.