An intervertebral body fusion device to be used in lumbar surgery
Medtronic has launched the Sovereign Spinal System in the US. The Sovereign Spinal System is an intervertebral body (interbody) fusion device used to treat patients who suffer from a degenerative condition that affects the lumbar spine. When a lumbar disc is diseased, it can lose height, compressing nerve roots and the spinal cord, causing pain in the legs and lower back, said the company.
The Sovereign Spinal System is designed to stabilise the spine and promote bony fusion, which involves the joining of two bones together, such as adjacent vertebrae. There are more than 200,000 lumbar fusion procedures performed each year to relieve leg and lower-back pain.
The new system incorporates a lens-shaped device with three holes for the placement of titanium screws, which protrude through the device and stabilise the adjacent vertebral bodies while preventing expulsion of the implant, said the company.
The company claims that the system also incorporates a cover plate that is designed to resist screw backout and that must be used in combination with the screws. Made of polyetheretherketone (PEEK), the Sovereign device is radiolucent on x-rays, which allows the surgeon to view the spinal fusion during a follow-up visit.
The System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous vertebral levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The implant may be implanted via a laproscopic or an open anterior approach, said the company.
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 Sovereign interbody device is intended to be used with the three titanium alloy screws and the accompanying cover plate.