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Cardiovasc Intervent Radiol. 2012 Apr;35(2):368-74. doi: 10.1007/s00270-011-0167-1. Epub 2011 May 28.

Percutaneous decompression of lumbar spinal stenosis with a new interspinous device.

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Department of Diagnostic and Molecular Imaging, Interventional Radiology, Nuclear Medicine and Radiation Therapy, University of Rome Tor Vergata, viale Oxford 81, 00133, Rome, Italy.



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.


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.


The mean ODI score decreased from 48.9 before the device implantation to 31.2 at 1 month (p < 0.0001). The mean VAS score decreased from 7.6 before to 3.9 (p < 0.0001) at 1 month and 3.6 at 3 months after the procedure (p = 0.0115). These values were stable at 6 months evaluation. No postimplantation major complications were recorded. MRI evaluation documented in most cases an increased size of the spinal canal area. Similarly a bilateral foraminal area improvement was found. The variation of the intervertebral space height measured on the posterior wall was not significant.


In our preliminary experience with the Falena in a small cohort of patients, we obtained clinical and imaging results aligned to those reported with similar interspinous devices.

[Indexed for MEDLINE]

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