Aesculap Implant Systems has received a letter of approval from the US 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 US 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 stabilisation. It is the first lumbar artificial disc with a mobile ultra-high molecular weight polyethylene core that supports both controlled translational and rotational movement similar to the movement of the healthy lumbar spine. The company says it offers the widest range of footprints and heights, including an 8.5mm design, which is the lowest height construct available on the market.
In the investigational device exemption (IDE) trial, the activL artificial disc demonstrated non-inferiority in overall trial success compared to conventional total disc replacement designs. In the analysis of primary outcomes from the IDE trial, the activL was non-inferior to the control devices tested but also had a greater overall success rate (p<0.0001). During their respective IDE trials, these conventional disc designs were compared to fusion surgery.
“The activL IDE trial outcomes add to the extensive body of evidence supporting the use of lumbar total disc replacement in risk stratified patients,” said Rolando Garcia of Aventura Medical Center, Aventura, USA, and activL IDE trial lead investigator who earlier this year co-authored the International Society for the Advancement of Spine Surgery’s position statement on lumbar total disc replacement. “Lumbar total disc replacement is a well-tested technology which should predictably lead to better outcomes and fewer complications than fusion surgery. I am excited to be able to offer the activL technology to my patients.”
“This is a landmark approval for Aesculap and represents a commitment to leading and advancing the care of the spine patient”, said James Yue, of Yale Medical Center and activL IDE trial lead investigator. “The activL disc replacement is a next generation biomimetic implant which has a number of innovative, unique implant and surgical design features.”
The activL artificial disc is indicated for reconstruction of the disc at one level (L4-L5 or L5-S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease with no more than Grade I spondylolisthesis at the involved level. The artificial disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL artificial disc should have failed at least six months of nonoperative treatment prior to implantation of the device.