The HydraFlex is a pre-formed hydrogel device that is implanted into the disc space to replace the diseased nucleus and maintain disc height while preserving motion. The treatment offers a potential early stage therapeutic solution for individuals with Degenerative Disc Disease.

The technology has been implanted in over 4,500 patients worldwide and is currently undergoing a Clinical Trial in the United States under FDA Investigational Device Exemption regulations.

Rocky Mountain Spine Arthroplasty Specialists is conducting a Clinical Trial using a new motion preservation, non-fusion device for Degenerative Disc Disease for use in patients between the age of 25 and 70.

You may be a candidate for this Clinical Trial involving this less invasive disc procedure if you have

Degenerative Disc Disease that has been causing low back pain that has not responded adequately to conservative (non-operative) treatment for at least 6 months.

The HydraFlex device is designed to replace the nucleus, or center portion of the disc in your low back, that is not functioning normally. The normal disc nucleus is a soft mucous-like substance contained within the center of the discs of your back that serves as a cushion to absorb shock between the vertebrae.

As the disc in your low back becomes degenerated, the nucleus loses its cushioning effect; this can

sometimes cause back pain. The HydraFlex device is surgically placed in the degenerated disc space to provide the cushioning effect of a normal nucleus.

If you have a MRI that demonstrates Degenerative Disc Disease at one level, and one or more of the

following problems, you may be considered for this new investigational technology:

• Localized tenderness in the lower back

• Increased back pain while:

•  Sitting

•  Driving

•  Bending forward