BRYAN Cervical Disc Gets FDA Approval

BRYAN® Cervical Disc, a product of Medtronic Sofamor Danek we first profiled back in 2007, has now been approved by the FDA. The implant, composed of a polyurethane and titanium discs designed to fit between adjacent vertebral bodies in the neck, is indicated “in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy,” according to the FDA.
From the FDA info page on the product:

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.

FDA approval : BRYAN® Cervical Disc – P060023…; Approval Order (.pdf); Summary (.pdf); Labeling (.pdf)
Flashbacks : Medtronic’s Bryan® Cervical Disc System; Medtronic’s Cervical Discs Deliver Good News to the Company