Here are five key notes:
1. The previous generation total disc replacement systems typically studied against fusion controls and surgeons in this study implanted either ProDisc-L or Charite as the control device.
2. The trial found activL artificial disc to be non-inferior to the control devices at the primary endpoint.
3. The protocol-defined analysis showed activL was superior due largely to the range of motion component of the primary composite endpoint.
4. The activL artificial disc features cobalt chromium endplates to affix to the patient’s vertebrae with bone-sparing spikes for initial stabilization. Aesculap received a letter of approval form the FDA in June 2015.
5. The Spine publication is the first of the outcomes expected from the anticipated activL artificial disc IDE trial, which will continue to the seven-year follow-up.
“Evidence like this is important to help motion preservation surgeons like myself defend our position with payers and increase our qualified patients’ access to motion preservation surgery,” said Glenn Butterman, MD, of Midwest Spine and Brain Institute in Stillwater, Minn., and an investigator on the activL trial. He also co-authored the publication.
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21 spine devices receive FDA 510(k) clearance in December
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