Aesculap Celebrates Five-Year Anniversary of the FDA Approval of the activL Artificial Disc: Five Years and Five Milestones
Center Valley, PA (June 18, 2020) - Aesculap Implant Systems, LLC today announced that it has been five years since the organization received FDA approval to market the activL® Artificial Disc in the United States. In the last five years, the data behind lumbar arthroplasty along with patients’ access to this procedure has continued to grow. Several significant milestones have charted the course:
- Now a standard of care for degenerative disc disease (DDD) in a specific patient subset. In 2017, a panel of surgeons at the North American Spine Society Annual Meeting (Orlando, FL) concluded that the evidence supports lumbar artificial disc replacement as a standard of care for a subset of DDD patients. Market awareness has increased dramatically with a more than threefold increase in the number of activL Artificial Disc credentialed surgeon implanters since the 2017 panel consensus.
- The protective effect of motion on the progression of adjacent segment disease (ASD) has been further studied and reviewed. Maintenance of range of motion (ROM) has a protective effect on delaying the progression of ASD in DDD patients. The post-hoc analysis of ASD from the activL Artificial Disc FDA study demonstrated that for every degree of motion maintained, patients experienced a lower incidence of ASD at five years. As a result, the activL Artificial Disc is less likely to result in progression of Adjacent Segment Disease which may lead to reoperations and lower patient satisfaction (p=0.05).
- Ninety-five percent of the activL Artificial Disc original FDA Investigational Device Exemption (IDE) study patients remained free from index level and adjacent level reoperation at five and seven years after surgery. The full dataset of five-year safety and efficacy outcomes from the activL Artificial Disc IDE study were published in Spine in 2019.
- The U.S. Commercial Coverage Landscape improves by 66 million lives. At the time of the FDA approval for the activL Artificial Disc, only 13% of commercially insured Americans had access to lumbar arthroplasty. With the strength of the long-term evidence and resources devoted to patient advocacy, 73% of Americans with commercial coverage now have access. Read the UnitedHealthcare coverage story at https://spinenation.com/buzz/unitedhealthcare-rsquo-s-new-positive-medical-policy-in-favor-of-lumbar-total-disc-replacement-reconfirms-the-procedure-rsquo-s-long-term-effectiveness-for-treatment-of-degenerative-disc-disease.
- The United States Defense Health Agency finds lumbar total disc replacement to be proven and medically necessary for active duty and retired U.S. military members and their families. Read about the 2018 TRICARE coverage decision at https://ryortho.com/breaking/tricare-covers-aesculap-lumbar-tdr/.
“It is rewarding to see the tremendous results of our team’s persistent conversations, strong clinical publication strategy and collaboration with spine surgeon advocates,” said Chuck DiNardo, President of Aesculap Implant Systems. “We would have done a disservice to U.S. spine patients if we had relented our focus.”
The activL Artificial Disc is a third generation motion preservation device designed to more closely mimic the natural biomechanics of the healthy human spine, thereby significantly reducing the impact on adjacent level anatomy. If you are a DDD sufferer interested in understanding your spinal fusion alternative options or if you need help navigating the Lumbar TDR insurance landscape, visit our patient website at https://www.aesculapimplantsystems.com/en/patients/about-your-lumbar-spine.html.