New Reconstructive Spinal Surgery

The procedure has been cleared by the U.S. Food and Drug Administration (FDA).

A miniature expandable instrument is used to shape a cavity inside the vertebral body. A conformable porous mesh sack, called OptiMesh, is then implanted into the damaged vertebra and filled with allograft, or donated bone material, to restore vertebral integrity. OptiMesh contains and reinforces the graft material, and the allograft tightly packed within OptiMesh becomes a solid implant augmenting the vertebra.

The first U.S. operation recently took place at the Northeast Georgia Medical Center (Gainesville, USA), performed by Karl D. Schultz, Jr., M.D., a neurosurgeon. The patient experienced an immediate and significant decrease in pain as a result of the surgery, and was discharged from the hospital within 24 hours.

The typical patient for the new procedure is female, over 60, with osteoporosis and sudden unremitting back pain due to minor trauma, according to Dr. Steve Kuslich, who invented the procedure and is now a spokesperson for Spineology, Inc. (Stillwater, MN, USA). Upon examination, a doctor may diagnose an osteoporotic compression fracture with accompanying loss of vertebral body height. If left untreated, the patient will often experience more fractures and develop a "dowager's hump.”

Spineology is a medical device company now commercializing the procedure. The company notes that an estimated 70,000 fragile bone vertebral fractures occur in the United States alone each year.




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