This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: BRYAN® Cervical Disc
PMA Applicant: Medtronic Sofamor Danek
Address: 1800 Pyramid Place, Memphis, TN 38132
Approval Date: May 12, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060023a.pdf
What is it? The BRYAN® Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain.
How does it work? Once the diseased disc is removed, the BRYAN® Cervical Disc is placed in milled pockets in the adjacent vertebral bodies. The device consists of two main metal pieces separated by a polyurethane part.
When is it used? The BRYAN® Cervical Disc is intended to be used to replace a cervical disc from C3-C7 following removal of the disc for intractable radiculopathy and/or myelopathy (conditions that result from a diseased or bulging disc). The patient should have failed at least 6 weeks of conservative therapy before receiving this device.
What will it accomplish? The device should help stabilize the operated spinal level. Unlike a fusion procedure, the BRYAN® Cervical Disc is designed to allow motion at the operated spinal level. The effects of the diseased disc removal should include pain relief and improved function.
When should it not be used? The BRYAN® Cervical Disc should not be implanted in patients with the following conditions:
- Active systemic infection or infection at the operating site;
- Allergy to titanium, polyurethane, or ethylene oxide residues;
- Osteoporosis defined as a DEXA bone mineral density T-score equal to or worse than -2.5;
- Moderate to advanced spondylosis characterized by bridging osteophytes, marked reduction or absence of motion, or collapse of the intervertebral disc space of greater than 50% of its normal height;
- Marked cervical instability on radiographs (e.g., radiographic signs of subluxation greater than 3.5 mm or angulation of the disc space more than 11 degrees greater than adjacent segments);
- Significant cervical anatomical deformity or compromised vertebral bodies at the index level (e.g., ankylosing spondylitis, rheumatoid arthritis, or compromise due to current or past trauma);
- Significant kyphotic deformity or significant reversal of lordosis; or
- Symptoms necessitating surgical treatment at more than one cervical level.
Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.