FDA Concerned with Cancer Rates for New Spine Device

Food and Drug AdministrationFDA reviewers expressed concern with the increased number of cancer cases seen in degenerative disc disease patients implanted with an investigational Medtronic spine device compared with patients who underwent spinal fusion. The Amplify device stabilizes lower back vertebrae in patients with degenerative disc disease by using a compression resistant matrix and a metallic posterior spinal instrument. Amplify contains rhBMP-2, a morphogenetic protein that is added to the device to spur the formation of new bone.

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FDA Okays Bryan Cervical Disc

The US Food and Drug Administration (FDA) has approved a novel artificial cervical disc, BRYAN, for the treatment of single-level cervical disc diseases like radiculopathy and/or myelopathy. The titanium-polyurethane disc, developed by Medtronic Inc, is implanted in milled pockets of adjacent vertebral bodies from C3-C7 to substitute a diseased or bulging natural cervical disc.