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Aesculap Implant Systems receives FDA clearance for new artificial disc

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Aesculap Implant Systems recently announced its receipt of a letter of approval from the FDA for the commercial sale of its activL Artificial Disc for the treatment of one-level lumbar degenerative disc disease.

According to an FDA overview of the new product, the activL Artificial Disc is intended to relieve pain and allow forward and backward motion at the spinal level for patients diagnosed with degenerative disc disease. The disc features cobalt chromium endplates, which affix to the patient’s vertebrae with bone-sparing spikes for initial stabilization.

In its Investigational Device Exemption (IDE) trial, the activL demonstrated non-inferiority in overall trial success compared with conventional total disc replacement designs, according to a company press release. In the analysis of primary outcomes from the IDE trial, the disc was found to be non-inferior to the control devices tested and also had a greater overall success rate.

The disc is approved for use in skeletally mature patients at one level (L4-5 or L5-S1) following single-level discectomy, according to the release.

Reference: www.aesculapimplantsystems.com.