Coflex Interlaminar Stabilization

Motion Preserving Minimally Invasive Treatment for Spinal Stenosis

The coflex device offers an alternative to lumbar fusion after spinal decompression. Dr. Pulliam participated in a clinical study which investigated the safety and effectiveness of coflex as one of 21 investigational sites from 2006–2010 and has performed around 15–20 coflex procedures since.

Potential benefits of coflex compared to fusion surgery include the following:

The coflex Interlaminar Technology is marketed by Paradigm Spine. For more information, visit their coflex product page. Please note that information regarding coflex is statistically derived and not all patients will have the same outcome. Your experience may vary.

Coflex Interlaminar Technology Information

From the FDA:

What is it? The coflex Interlaminar Technology is a U-shaped, titanium alloy implant that fits between two bones called the spinous processes located in the lower back (lumbar region) of the spine. The device is placed between two adjacent lower back bones after surgical relief of pressure on the spinal cord and nerves (decompression) to ease the pain associated with lumbar spinal stenosis, a narrowing of the passages for the spinal cord and nerves.

How does it work? The coflex device is designed to maintain a fixed distance between the spinous processes of two lumbar segments following surgical decompression. By limiting the ability to bend backward (extension) in the affected area, the device may relieve the symptoms of lumbar spinal stenosis.

When is it used? The coflex device is intended to be implanted in the center (midline) between 1 or 2 adjacent segments of the lumbar region of the back (from L1-L5) to provide stability following surgical decompression of spinal stenosis at the affected level(s).

The coflex device is indicated for skeletally mature patients (people who have stopped growing) who experience relief from their symptoms of leg/buttocks/groin pain, with or without back pain when bending forward, and who have undergone at least 6 months of non-operative treatment.

What will it accomplish? This device should help relieve some or all of the symptoms of lumbar spinal stenosis. Unlike a fusion procedure, the coflex device is designed to allow some motion at the affected level(s).

Click here for complete FDA information.

Peer Reviewed Evidence

Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial

“The results of this study with 5-year follow-up support that decompression and ILS is an effective and sustainable treatment option for moderate to severe spinal stenosis and not an inevitable precursor to fusion. ILS after decompression produces outcomes similar or superior to fusion with pedicle screws.”

Musacchio, Michael and others. January 2016; International Journal of Spine Surgery. Link to article.

Comparative cost effectiveness of Coflex® interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis

“The average index hospitalization savings among potential Medicare enrollees for a Coflex hospitalization compared with a fusion hospitalization was $11,096, while for private insurance the savings averaged $14,286. Over the 5-year follow-up period, costs were projected to be $15,182 for patients who received the Coflex procedure and $26,863 for patients who underwent a fusion, a difference of $11,681 per patient. At the same time, patient-reported utilities were observed to be slightly higher among Coflex patients. In short, Coflex stabilization achieves clinical equivalence with substantial cost savings compared with fusion.”

Schmier JK, Halevi M, Maislin G, Ong K. March 2014; ClinicoEconomics and Outcomes Research. Link to article.

Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment

“This study demonstrates that coflex interlaminar stabilization is associated with improved clinical, safety, and radiographic outcomes at 48 months post-op when compared to fusion in the studied patient population. When considering factors hypothesized to be associated with longer-term therapeutic sustainability and durability, ILS is again superior to fusion.”

Bae, Hyun and others. May 2015; International Journal of Spine Surgery. Link to article.

Additional Studies

To view additional studies relating to coflex, visit Paradigm Spine's peer-reviewed article listing.