The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Tuesday, September 19, 2006 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 Medtronic Sofamor Danek for the Prestige Cervical Disc System (P060018) intended to treat skeletally mature patients with degenerative disc disease (DDD) at one level from C3-C7.
The meeting began with the Deputy Director of the Division of General, Restorative and Neurological Devices giving the panel an update of device approvals and FDA staff changes since the last meeting. The sponsor and FDA presentations focused on preclinical and clinical data collected on the subject device. Preclinical testing consisted of bench testing, cadaver and animal particulate testing. The clinical data were collected in a prospective, randomized, concurrently controlled (anterior cervical fusion) multi-center study intended to assess the safety and effectiveness of the Prestige Cervical Disc System for treatment of cervical DDD at a single cervical from C3-C7 by demonstrating non-inferiority to the control treatment. The study’s primary endpoint defined independent patient success as at least a 15 point improvement in the Neck Disability Index (NDI) score, lack of implant-related serious adverse events, maintenance or improvement of neurological status, and no secondary surgical procedures, and maintenance of functional spinal unit (FSU) height. Non-inferiority to the control treatment was demonstrated in Bayesian analyses both with and without FSU height included.
The Panel unanimously voted (7-0-0) to recommend that the PMA application for the Prestige Cervical Disc System be found “Approvable with Conditions.” The recommended conditions of approval are summarized as follows:
- The indicated patient population should be limited to the population studied
- The effectiveness claims should be limited to non-inferiority
- There should be a post approval animal study to look at long-term bone/implant interface performance and the fate of the particulates that are generated
- There should be a post approval clinical study that, in addition to the sponsor’s proposed post approval study, includes radiographic evaluations to detect radiolucencies, evaluation of device removals and analysis of retrievals (including the individual components as well as histological specimens), and data on adjacent level surgeries and adjacent segment disease.
- The educational materials (e.g., patient information) should be revised to remove the language that motion implies less adjacent segment degeneration and/or effectiveness
Contact: Ronald P. Jean, Ph.D., Executive Secretary, at 301-594-2036, x181 or email@example.com.
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