The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Tuesday, July 15, 2008 at the Hilton Washington DC North/Gaithersburg located at 620 Perry Parkway in Gaithersburg, Maryland. The Panel met in order to provide advice and a recommendation on the approvability of the Premarket Approval (PMA) application submitted by FzioMed, Inc., for the Oxiplex/SP Gel (P070023). This device is intended to be used as a surgical adjuvant during posterior lumbar laminectomy, laminotomy, or discectomy to improve patient outcomes by reducing postoperative leg pain, back pain and neurological symptoms.
The meeting began with the Acting Chief of the Orthopedic Spine Devices Branch within the Division of General, Restorative and Neurological Devices giving the panel an update of orthopaedic-related PMA approvals, guidances and FDA staff changes since the last meeting. The sponsor and FDA presentations focused on pre-clinical testing and clinical data collected on the subject device for patients having data. The sponsor presented the subset of patients having data within the pre-specified visit window at 6 months. The FDA presented all patients having data within 12 months (as results were similar to FDA's analyses of the ITT patient population proposed by the IDE). The FDA also provided an analysis based upon the sponsor’s original IDE statistical plan, while the sponsor presented a multivariable analysis that was derived from the statistical analyses plan approved at a later date. The Oxiplex/SP Gel study results (based on a post hoc subgroup of the patients having back pain LSOQ score of greater than or equal to 63 and having data within the 6-month visit window) were found to demonstrate statistical significance, while the analysis on the overall patient population did not demonstrate statistical significance.
The Panel voted (5-2-0) to recommend that the PMA application for the Oxiplex/SP Gel be found “Not Approvable.” While acknowledging that Oxiplex/SP Gel appeared to be safe and potentially held promise in the future, the Panel was not convinced that the study results demonstrated effectiveness, and recommended that future consideration be given to understanding the physiological mechanism of action to better help with selection of the target population, as well as to design of a future study, including issues of sample size, controlling site variability, randomization and blinding.
Contact: Ronald P. Jean, Ph.D., Executive Secretary, at 240-276-3676 or email@example.com.
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