Percutaneous Decompression of Lumbar Spinal Stenosis with a New Interspinous Device

Objective This study was designed to evaluate the feasibility of the implantation of a new interspinous device (Falena) in patients with lumbar spinal stenosis. The clinical outcomes and imaging results were assessed by orthostatic MR during an up to 6-month follow-up period. Methods Between October 2008 and February 2010, the Falena was implanted at a single level in 26 patients (17 men; mean age, 69 (range, 54–82) years) who were affected by degenerative lumbar spinal stenosis. All of the patients were clinically evaluated before the procedure and at 1 and 3 months. Furthermore, 20 patients have completed a 6-month follow-up. Pain was assessed before and after the intervention using the Visual Analogue Scale score and the Oswestry Disability Index questionnaire. Orthostatic MR imaging was performed before the implantation and at 3 months to assess the correlation with the clinical outcome. Results The mean ODI score decreased from 48.9 before the device implantation to 31.2 at 1 month ( p