Aesculap Receives FDA Approval for the activL® Artificial Disc for One-Level Lumbar Use (press release)
Intelligent Motion Technology for Total Disc Replacement; activL Is Designed as an Alternative to Spinal Fusion Surgery to Allow Motion at the Treated Level of the Lower Back
Aesculap Implant Systems, LLC (Aesculap), a privately held medical device company, announced today that it has received a letter of approval from the U.S. Food and Drug Administration (FDA) allowing the commercial sale of the activL® Artificial Disc, for the treatment of one-level lumbar degenerative disc disease.
Chuck DiNardo, Aesculap President, commented, "We are very pleased that the FDA has determined activL to be safe and effective for lumbar total disc replacement. We are excited to be the first medical device company in ten years to introduce a new lumbar disc to the market. This U.S. approval is validation of Aesculap's commitment to introducing innovative technologies that give patients alternatives to the standard of care."
The activL Artificial Disc features cobalt chromium endplates which affix to the patient's vertebrae with bone-sparing spikes for initial stabilization. It is the first lumbar...
