Coflex
Interlaminar Stabilization
A minimally invasive posterior lumbar motion preservation solution that addresses leg and back pain and has proven long-term outcomes for durable pain relief and stability.
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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.
Coflex Device
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.
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.
Interspinous
Distraction
- Intermittent Neurogenic Claudication
- Insignificant Back Pain
- Too Sick for General Anesthesia
Decompression
Alone
- Mild to Moderate Stenosis
- OPI < 40
- With NO Low Back Pain
- With NO Spondylolisthesis
- With NO Instability
Decompression
& Coflex
- At Least Moderate Stenosis
- OPI > 40
- Significant Back Pain (> leg pain)
- NO Spondy up to Stable Grade 1 Spondylolisthesis
- NO Instability or Anticipated Instability
Spinal
Fusion
- Mild to Severe Stenosis
- OPI > 40
- Back Pain (VAS > 50)
- > Grade 1 Spondylolisthesis
- Gross Instability / Deformity
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 stay
PsiF Surgical Tray
- Trial sizes: 8/10/12/14/16mm
- Wing Trial
- Bending Pliers
- Crimper Pliers
- Mallet
- Sterilization Tray
Safety, Effectiveness, and Reliability
The Coflex® Interlaminar Stabilization® device is the only lumbar spinal device with Level 1 evidence in two separate clinical studies. The Coflex device has been implanted in more than 175,000 patients in over 60 countries.