Healio
Healio
May 28, 2009
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Bryan cervical disc receives FDA approval for one-level radiculopathy and myelopathy indications

The FDA has approved the premarket approval application for the Bryan Cervical Disc, manufactured by Medtronic Sofamor Danek in Memphis, according to documents on the FDA Web site.

In approving the titanium and polyurethane Bryan Cervical Disc device on May 12, FDA officials have brought another surgical option to patients whose spine levels from C3 to C7 need stabilizing after discectomy.

FDA officials followed the recommendation for approval that its Orthopaedic and Rehabilitation Devices advisory panel made in 2007, when panel members voted 7-1 in favor of approving the implant, with conditions.

The Bryan Cervical Disc is indicated for use in treating intractable radiculopathy and/or myelopathy from diseased or herniated cervical discs after patients fail a minimum of 6 weeks of conservative treatment. The prosthesis is implanted through an anterior approach and was designed to facilitate increased motion in the operated segments, according to the FDA Web site.

According to the approval information provided by the FDA, the implant is contraindicated in some cases, such as in individuals with active local infection, poor bone mineral density, extreme spondylosis, deformity and multi-level disease.

Medtronic’s premarket approval application (PMA P060023) included a prospective, randomized multicenter trial comparing outcomes with the Bryan total disc replacement device to those of anterior cervical discectomy and fusion at a single level. Results in the 431 study patients who were followed up through 24 postoperative months showed overall success rates based on improvement in the Neck Disability Index of 80.6% in the disc device group vs. 70.7% in the fusion group.

According to the approval letter that Donna-Bea Tillman, PhD, MPA, director of the Office of Device Evaluation, Center for Devices and Radiological Health, sent to Medtronic Sofamor Danek, three areas require additional postapproval data.

Medtronic must conduct a 10-year postapproval study to report longer-term safety and efficacy results, as well as a 5-year surveillance study to elucidate any adverse events seen with broader use of the product. They must also submit revised labeling through a PMA supplement to reflect any important information revealed by those studies and other investigations, according to the letter.

Medtronic is planning a controlled market release of the product in July, a company spokesperson said.

In July 2007, the FDA approved Medtronic’s Prestige Cervical Disc for clinical use. It was the first cervical artificial disc cleared for use in the United States.

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