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www.fdanews.com/articles/171702-aesculaps-activl-artificial-disc-wins-fda-approval

Aesculap’s activL Artificial Disc Wins FDA Approval

June 15, 2015

Aesculap Implant Systems has won FDA marketing clearance for its activL artificial disc for one-level lumbar degenerative disc disease treatment, the Center Valley, Pa., devicemaker announced Monday.

Meant as an alternative to spinal fusion surgery, which can be associated with complications, the device uses cobalt chromium endplates to affix to the vertebrae with bone-sparing spikes providing initial stabilization.

Prior to device implantation, patients should have failed at least six months of nonopertaive treatment, the company adds. — Jason Scott