What is coflex®?

One thing we value most in life is our ability to walk and do activities independently. As we get older, activities of daily living are often robbed by spinal stenosis. Simple things such as working around the house, gardening, grocery shopping, or walking for exercise or recreation can trigger symptoms of spinal stenosis, resulting in pain, numbness, or weakness in your lower extremities.

For the past 20 years, patients with moderate to severe spinal stenosis have been treated with a fusion technique that uses metal rods and screws, which eliminates motion in the spine after surgical decompression. However, the coflex® Interlaminar Stabilization procedure is a new, non-fusion solution that allows you to be able to do the things you love most! The coflex® device is a titanium metal implant that helps keep your spine stable after surgical decompression. The coflex® device also helps maintain the normal foraminal height and motion in your spine where the coflex® was implanted. It’s amazingly strong, yet simple, and flexible enough to support your spine without having to fuse your bones together.

Benefits

Compared to fusion patients in a FDA clinical study*, the patients receiving the coflex® device experienced:

  • Faster Symptom Relief - At 6 weeks, coflex® patients showed early relief of their spinal stenosis symptoms compared to fusion patients (90% vs. 77%, measured by ZCQ div-layer with text definition)
  • Lasting Symptom Relief  - At 2 years, coflex® patients showed lasting relief of their spinal stenosis symptoms compared to fusion patients (88% vs. 78%, measured by ZCQ div-layer with text definition)
  • Patient Satisfaction - At 2 years, coflex® patients were satisfied with their outcome compared to fusion patients (94% vs. 87%)
  • Shorter operating time - coflex® surgeries were 36% faster compared to fusion surgeries (98 minutes vs. 153 minutes).
  • Shorter hospital stay - coflex® patients spent 40% less time in the hospital compared to fusion patients (1.9 days vs. 3.2 days).
  • Less Blood Loss - coflex® patients had less blood loss during surgery compared to fusion patients (110cc vs. 349cc).
  • Stability in the Treatment Area - At 2 years, coflex® patients retained their pre-operative range of motion (within 10%) and translation (within 5%) at the area of treatment.
  • More Natural Movement at Treatment Area and Surrounding Spinal Segments - At 2 years, coflex® patients retained their pre-operative range of motion (within 15%) at the areas below and above the treatment area, and fusion patients saw a 25-50% increase in unnatural motion at the areas below and above the treatment area.
* This data is based on validated clinical measurements from a randomized FDA clinical study comparing the coflex® Interlaminar Technology to pedicle screw fusion surgery for moderate to severe spinal stenosis. Every patient is different; therefore, results may vary. All data is on file at Paradigm Spine, LLC.

The coflex® Solution is a 21st century medical procedure designed to be superior to traditional spinal fusion surgery for spinal stenosis. Compared to fusion surgery, the coflex® procedure offers quicker recovery, greater movement and better pain relief. You’ll be amazed by how it restores your quality of life.

How The coflex® Solution Works

After a decompression surgery, your spine can become unstable or insecure, and needs something to help keep it steady. The coflex® device keeps your spinal column healthy and stable after surgical decompression and helps uphold the normal foraminal height of your spine in the affected area. Unlike a fusion procedure, the coflex® implant maintains mobility and function, allows you to bend forward and backward without pain, and helps other spinal segments in your spine maintain their natural motion. The coflex® interlaminar device is specifically designed to be placed on the laminar bone, which is the strongest part of the spine in your lower back. The coflex® procedure is a simple surgery and is implanted through the same small incision as your surgical decompression, minimizing injury done to tissue and muscle near your spine. Download our coflex® Patient Education Pamphlet for more information!

FDA Tested and Approved

In the FDA clinical study, the coflex® device was compared to pedicle screw spinal fusion surgery (surgical decompression with spinal fusion surgery for spinal stenosis). The objective of this study was to see if the coflex® device was safe and if it would work in patients who had moderate to severe spinal stenosis. In the FDA study, it is proven that the coflex® device is a reasonable alternative to pedicle screw fusion, and results showed that coflex® patients outperformed fusion patients in all clinical measurements!* 

LEARN MORE and see how coflex® patients did compared to fusion patients in the FDA Study.

coflex® In the News

The coflex® Interlaminar Stabilization™ device has been widely adopted across the United States since its FDA approval in 2012. Get a glimpse of the coflex® device and its media coverage from not only when it was under investigational study by the FDA, but also since its approval. Read more about coflex® in the news.

Risks

As a patient, there is always potential risk in having surgery or getting a medical device. Usually these risks are rare. You should refer to the coflex® Patient Labeling (Contact us to receive your own coflex® information brochure) for a list of all potential risks and hazards that were observed during the clinical study. For patients receiving coflex®, the biggest risk is continued pain. Other risks include wound healing problems (such as infection or drainage), brief numbness or tingling in your arms or legs, and spinous process fractures. Some patients had illnesses or diseases not related to their surgery, like problems with their skin, problems breathing, problems with their heart, and other muscle or bone pain or soreness. In the clinical trial, similar problems were experienced with patients who had fusion. The coflex® surgery may not help relieve pain in some patients, and you may need another surgery to remove the device. It is hard to predict who will not benefit from this surgery.

*Data is based on validated clinical measurements from a randomized FDA clinical study comparing the coflex® Interlaminar Technology to pedicle screw fusion surgery for moderate to severe spinal stenosis. Every patient is different; therefore, results may vary. All data is on file at Paradigm Spine, LLC.