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FDA advisory committee recommends approval of new cervical disc system

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The FDA Orthopaedic and Rehabilitation Devices advisory panel unanimously voted to recommend approval of Medtronic Inc.'s Prestige Cervical Disc System, the company announced.

However, the approval recommendation is subject to additional conditions regarding product labeling and post-approval testing, according to a press release from Medtronic.

The Prestige Cervical Disc System is a two-piece articulating stainless steel implant intended as an alternative to spinal fusion in patients with degenerative disc disease (DDD). The device is designed to replace a diseased disc while maintaining both motion and flexibility of the cervical spine.

Researchers evaluated the system in a prospective, multicenter and randomized clinical trial involving 541 skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. In the study, 276 patients were implanted with the Prestige device and 265 control group patients received an anterior-plated surgical fusion involving bone graft and plate stabilization.

At 2 years follow-up, patients implanted with the Prestige system showed results equal to or better than patients in the control group, including neck disability index, functional spinal unit height and overall success, according to a summary of effectiveness data presented to the committee by Medtronic.

"We are pleased with the panel's actions today because it brings this important technology one step closer to availability in the U.S.," Ken Burkus, MD, of the Hughston Clinic in Columbus, Ga., said in the release. "We look forward to working with the FDA to obtain final approval."

For more information:

• Briefing information presented to the FDA Orthopedics and Rehabilitation Devices advisory committee, including summaries of the Prestige Cervical Disc System's safety and efficacy, can be found on the FDA Web site at: www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4243b1_00_index.htm.