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Norwalk Hospital To Participate In Globus Medical’s Clinical Trial For Treatment Of Lumbar Spinal Stenosis

Norwalk Hospital has been selected to participate in an FDA-approved national clinical trial of the Globus Medical's FLEXUS Inter-Spinous Spacer for the treatment of Lumbar Spinal Stenosis (LSS). The objective of the clinical trial is to evaluate the effectiveness of the FLEXUS Inter-Spinous Spacer as compared to the control procedure, the currently FDA-approved X-STOP Interspinous Process Distraction Device for the treatment of lumbar spinal stenosis. The study will involve 340 subjects (170 investigational and 170 control) at 20 sites across the country. It is anticipated that the results of the study will be used to support regulatory approval for the new device. Globus Medical’s FLEXUS Spacer is placed with a unilateral approach between two spinous processes with minimal disruption to surrounding muscle and tissue. The device requires no intra-operative assembly and involves only a single incision to insert. The company manufactured the device from PEEK radiolucent polymer rather then titanium to more closely match the biomechanical properties of bone. Patients 50 years of age and older who have been diagnosed with Lumbar Spinal Stenosis and who have undergone a minimum of six months of conservative therapy, as well as met other various criteria, may qualify for the study.