How does the coflex^®
clinical research study work?

Over 25,000 people outside the U.S. have been implanted with the coflex^® investigational device. Based on those results, a clinical research study has been launched in the United States. This clinical research study will evaluate the safety and effectiveness of the coflex device against the control, which is pedicle screw fixation and spinal fusion.

Qualifying for the study

In order to be eligible to participate in the coflex clinical research study all patients must meet the inclusion criteria. These criteria are carefully thought out to include those patients who are the best possible candidates for the clinical research study. General inclusion criteria include:

• Between 40 and 80 years of age.
• Moderate to severe spinal stenosis.
• Have undergone at least six (6) months of prior conservative
  care, including one (1) epidural injection, without adequate and sustained relief.
• While many prior back surgeries are within the inclusion criteria, you must not have had a spinal fusion in the past.

This is just a partial list of criteria for acceptance into the clinical research study. Only a clinical research study staff member can make that determination, but you can take the first step by calling to find out more.

For more information on the coflex clinical research study, or to see if you might be eligible to participate, call 1-866-493-9510 Mon–Thurs, 7am–7pm and Fri, 7am–6pm, CST.

CAUTION: Investigational device.Limited by Federal (or United States) law to investigational use.