CENTER VALLEY, PA–(Marketwired – June 15, 2015) – 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 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. It offers the widest range of footprints and heights, including an 8.5 mm design, which is the lowest height construct available on the market.
“We approach our business from the patient backwards,” continued DiNardo, “We have to thank our investigators and the patients enrolled in the trial. Their participation and commitment to this study has granted many more U.S. patients access to this next generation motion preserving technology. We are now starting our U.S. activL surgeon training and education.”
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 Artificial Disc 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, MD of Aventura Medical Center, Aventura, Florida 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 less complications than fusion surgery. I am excited to be able to offer the activL technology to my patients.”
“I congratulate my co-developer Dr. Rolando Garcia and the focused and tireless efforts of the Aesculap team in obtaining U.S. FDA approval of the activL lumbar disc replacement prosthesis,” said James Yue, MD of Yale Medical Center and activL IDE Trial lead investigator. “This is a landmark approval for Aesculap and represents a commitment to leading and advancing the care of the spine patient. The activL disc replacement is a next generation biomimetic implant which has a number of innovative, unique implant and surgical design features.”
The Aesculap Implant Systems 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. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® 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.
