The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Tuesday, August 31, 2004, in Gaithersburg, MD.
The Panel made a recommendation to the Food and Drug Administration (FDA) on the approvability of a premarket approval application (PMA) for the St. Francis Medical Technologies, Inc., Alameda, CA, X STOP Intraspinous Process Decompression System (the “X STOP®”), PMA P040001. The X STOP® is indicated for patients aged 50 or older suffering from mild to moderate neurogenic intermittent claudication secondary to lumbar spinal stenosis who have undergone a regimen of non-operative treatment, and who experience relief in flexion from their symptoms of leg/buttock/groin pain, with and without back pain.
Following presentations by the sponsor, the FDA, and two Panel members, the Panel deliberated on the information in the submission and considered the FDA discussion questions. The Panel then voted five to three to recommend to the FDA that the PMA be found 'not approvable.' The Panel cited concern with the need to identify the patient population that is most likely to benefit from the device, noting that overall effectiveness was not demonstrated in a majority of the clinical study population. The Panel also cited concerns with the longer term effectiveness of the device (longer than two years), with potential bias in the clinical study, and with the need for radiographic or other objective evidence of the device’s mechanism of effect on the spine in patients. Panel members discussed several options for how they believed the sponsor could address the concerns and put the PMA in an approvable form.
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