Medtronic, Inc. (NYSE: MDT) today announced the U.S. launch of the
SOVEREIGN™ Spinal System.
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. The SOVEREIGN Spinal System is designed to
stabilize 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.
To restore a patient’s disc height, surgeons have traditionally used
bone grafts, stabilized and held in place by metal plates anchored to
the spine with bone screws. The SOVEREIGN Spinal 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 preventing expulsion of the implant. 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.