The NeuDisc has not been approved by the Food and Drug Administration and is
an experimental device not available for sale. The NeuDisc is currently
undergoing preclinical testing. Replication Medical, replicating the disk
nucleus for the treatment of degenerative disk disease. Low back pain
afflicts at least six million Americans annually back pain is often associated
with degenerative changes in the spinal discs, which take place over time. With
aging, the jelly-like material in the nucleus of the disc loses its ability to
take up fluid and produce pressure in the disc. Without pressure the nucleus
will not cushion the spine and elements of the spine can be compressed, leading
to pain - this condition is known as degenerative disc disease.
This investigational product, known as the NeuDisc, would replace a degenerated
nucleus with a material intended to mimic the behavior of native healthy
nucleus, with hydrogel material that swells in the presence of fluid and
re-pressurizes the disc. A polymer mesh in the NeuDisc structure is designed to
limit movement and help ensure that the NeuDisc does not penetrate through the
annulus. Proper position of the NeuDisc can be visualized radiographically due
to the platinum-iridium wires that are embedded in the device. At the beginning
of a new disc implant procedure a discectomy is performed to remove the
unhealthy nucleus pulposus and create a space for the NeuDisc to reside.
A special set of orthopedic instruments have been designed to make implanting
the NeuDisc easier and more streamlined. First, the working tube is inserted in
its open position. As the working tube is closed the tips of the working tube
separate causing the disc space to distract. The working tube is held in the
closed position by sliding the frame connector over the closed tube. For
convenience, the frame adapter can be used to attach the working tube to a
standard surgical frame or arm. In preparation for inserting the NeuDisc
into the intervertebral disc space, the NeuDisc is slid into the tip of the
inserted instrument with the NeuDisc's polymer mesh layers aligned with the
instruments laser marked lines. The inserter is then placed into the working
tube until fully seated. The inserter screw is slowly turned
clockwise to drive the NeuDisc into the disc space. Radiographic imaging is used
to ensure that the NeuDisc is positioned at the midline of the disc.
The direction of rotation may be reversed to assure proper positioning of
the NeuDisc. Once the NeuDisc is in the desired location, it is released from the
inserter and all instruments are removed. Radiographic imaging of the wires within
the new disc is used to ensure that the implant is positioned properly at the
midline of the disc. The disc space containing the NeuDisc
is irrigated with normal saline to allow the implant to begin swelling. The
NeuDisc continues to slowly absorb body fluids and swell until it conforms to
the surrounding anatomy. The NeuDisc is intended to completely fill the
denucleated space and apply a lifting force to the vertebral endplates. Since
the NeuDisc is designed to be comfortable and flexible, it should bend
rotate, and move with the spine, which would allow for full movement, without
subjecting the end plates to high stress. And like a healthy nucleus, the NeuDisc
is expected to respond to the diurnal pressure cycle in the spine by respiring,
slowly expelling, and absorbing fluid in response to load changes circulating
fresh fluid through the intervertebral space. Replication Medical - replicating
the disk nucleus for treatment of degenerative disc disease.