Innovative PEEK Spinal System for Lumbar Surgery

The patients should be skeletally mature and have had six months of nonoperative treatment. The system incorporates a lens-shaped device with three holes for the placement of titanium screws, which protrude through the device and stabilize the adjacent vertebral bodies, while concomitantly preventing expulsion of the implant. The system also incorporates a compulsory cover plate designed to resist screw ejection that must be used anytime the device is used, with any number of screws. Made of polyetheretherketone (PEEK), the device is radiolucent on X-rays, which allows the surgeon to view the spinal fusion during a follow-up visit.

The Sovereign intervertebral body fusion device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the device is intended to be used with the three titanium alloy screws and the associated cover plate. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation must be used to augment stability. The device may be implanted via a laparoscopic or an open anterior approach. The Sovereign Spinal System is a product of Medtronic (Memphis, TN, USA), and has been approved by the U.S. Food and Drug Administration (FDA).

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