Physician Resources
Newly Available, Newly Approved
Am J Orthop. 2008 March;37(3):173
New System With Breaking Hinge
| Mizuho OSI has introduced the new Axis Jackson™ System. Featuring a proprietary hinge that is controlled by a powered hand pendant, the Axis Jackson allows the surgeon to manipulate the patient’s position intraoperatively. An engineered system of synchronized, moving elements provides harmonious translation of the patient’s torso during spinal flexion and extension events, thus avoiding distraction or compression of the spine. One of 5 modular surgical table tops that fit onto a single table base, the Axis Jackson System consists of a hinged Axis Jackson frame and a 2-piece supine top. The Advanced Control Base of the modular table system can host other table tops in addition to the Axis Jackson for specific surgical procedures. To learn more, contact at Mizuho OSI |
Generic Fosamax Approved
| The U.S. Food and Drug Administration has approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis. Teva Pharmaceuticals USA, North Wales, Pa., was approved to manufacture alendronate sodium tablets in 3 once-daily dosing strengths (5 milligrams, 10 milligrams, and 40 milligrams) and 2 once-weekly dosing strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., Montvale, NJ, was approved to manufacture a 70-mg once-weekly dose of the drug. The labeling of the generic alendronate sodium tablets may differ from that of Fosamax because some portions of the labeling are protected by patents and exclusivity. For more information, visit FDA’s Office of Generic Drugs |
Total Disc Replacement
| Synthes has announced that the FDA has fully approved the ProDisc®-C Total Disc Replacement for commercial sale and distribution in the United States. The company emphasizes that the ProDisc-C Total Disc Replacement procedure is intended to significantly reduce pain caused by cervical disc degeneration. This is done by allowing for the removal of the diseased disc while restoring disc height and providing the potential for motion at the affected vertebral segment. The FDA’s approval included a review of the results of a human clinical trial of the ProDisc-C conducted over the course of 3 and 1⁄2 years. The study involved 209 patients at 13 clinical sites and compared disc replacement using the ProDisc-C with anterior cervical discectomy and fusion, which is the current standard of care. Patients were evaluated for pain and disability, neu |