Centerpulse Spine-Tech Inc has received U.S. Food and Drug Administration (FDA) approval to begin marketing the radiolucent BAK Vista Interbody Fusion System for use in ALIF or PLIF surgical approaches.

"The BAK Vista System is the only radiolucent stand-alone implant option available to surgeons today," said Mike McCormick President of Centerpulse's Spine-Tech USA Division. McCormick went on to say "The BAK Vista implant will allow clear, radiologic visualization of fusion, providing surgeons a new level of confidence in fusion assessment."

Lumbar fusions are a common treatment for disabling low back pain and leg pain stemming from degenerative disc disease. The BAK Vista System maintains the proven design features of the original BAK implant and is consistent in its surgical technique and instrumentation to the BAK Interbody Fusion System. Tantalum beads imbedded in the anterior and posterior edges of the implant allow for x-ray confirmation of implant location.

Dr. Paul C. McAfee, of Scoliosis and Spine Center in Baltimore, said, "Unlike metal implants, the radiolucent BAK Vista implant does not cause artifacts or flares on x-ray, MRI or CT scans, which provides surgeons with an important fusion assessment tool for the lumbar spine."

"The radiolucent BAK Vista implant is based on the original design of the gold standard BAK implant, which now has over 6 years of proven clinical data," said Dr. John E. Sherman, of Twin Cities Orthopedics in Edina, MN. Since it inception in 1991, Centerpulse Spine-Tech is the pioneer in interbody fusion with the first strong, reliable and proven cage implant for both the lumbar and cervical areas of the spine.

The BAK Vista System will be available immediately in the U.S. and featured at the upcoming medical association meetings.