Medical Devices: Evidence and Research (May 2016)
The activL® Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain
Abstract
James J Yue,1 Rolando Garcia Jr,2 Larry E Miller3 1Department of Orthopaedic Surgery, Yale School of Medicine, New Haven, CT, 2Orthopedic Care Center, Miami, FL, 3Miller Scientific Consulting, Inc., Asheville, NC, USA Abstract: Degeneration of the lumbar intervertebral discs is a leading cause of chronic low back pain in adults. Treatment options for patients with chronic lumbar discogenic pain unresponsive to conservative management include total disc replacement (TDR) or lumbar fusion. Until recently, only two lumbar TDRs had been approved by the US Food and Drug Administration - the Charité Artificial Disc in 2004 and the ProDisc-L Total Disc Replacement in 2006. In June 2015, a next-generation lumbar TDR received Food and Drug Administration approval - the activL® Artificial Disc (Aesculap Implant Systems). Compared to previous-generation lumbar TDRs, the activL® Artificial Disc incorporates specific design enhancements that result in a more precise anatomical match and allow a range of motion that better mimics the healthy spine. The results of mechanical and clinical studies demonstrate that the activL® Artificial Disc results in improved mechanical and clinical outcomes versus earlier-generation artificial discs and compares favorably to lumbar fusion. The purpose of this report is to describe the activL® Artificial Disc including implant characteristics, intended use, surgical technique, postoperative care, mechanical testing, and clinical experience to date. Keywords: activL® Artificial Disc, artificial disc, degenerative disc disease, discogenic, implant, lumbar, motion preservation, pain