Medtronic has announced the European launch of the Sovereign Spinal System.
The Sovereign Spinal System is an intervertebral body (interbody) fusion device used to treat patients who suffer from degenerative disc disease affecting the lumbar spine. When a lumbar disc is diseased, it can lose height, compressing nerve roots and the spinal cord, causing pain in the lower back. 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.
The Sovereign Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilise the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with three holes for placement of titanium screws. The Sovereign interbody device is intended to be used with the three titanium alloy screws which accompany the implant. If the physician chooses to use less than three, or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability. If the physician chooses to use screws with the implant, the accompanying cover plate must be used. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The Sovereign Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Degenerative disc disease 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. These implants may be implanted via a laparoscopic or an open anterior approach.
The Sovereign Spinal System incorporates technology developed by Gary K Michelson.