Aesculap Implant Systems Announces the Long-Term Reporting from its Pivotal IDE Trial for the activL® Artificial Disc
Center Valley, PA (July 26, 2021) - Aesculap Implant Systems, LLC, a leader in lumbar motion preservation technology, today announced the e-publication of the “Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease, 7-Year Results” in the International Journal of Spine Surgery. The study reports patient outcomes at seven years post procedure, comparing the activL Artificial Disc, the latest generation lumbar total disc replacement (TDR), with the previous generation disc replacement system – ProDisc-L – in the treatment of patients with symptomatic single-level lumbar degenerative disc disease (DDD).
The activL Artificial Disc is designed to preserve motion at a single level (L4-L5 or L5-S1) of the spine by replicating the performance of the intact intervertebral disc. The long-term evidence from the FDA non-inferiority study presented in this paper supports lumbar TDR as a safe and effective treatment option for DDD. At seven years, the activL Artificial Disc demonstrates prolonged significant improvements in back/leg pain, disability index and quality-of-life relative to baseline.
Additionally, the study shows that activL Artificial Disc patients have significantly better range of motion (ROM) for flexion-extension rotation than ProDisc-L patients (p=0.033) at seven years and that significantly fewer activL Disc patients report serious safety issues than ProDisc-L patients (p=0.011). Predictive modeling demonstrates that most patients lost to follow-up at two years have clinically significant benefits with the activL Artificial Disc at seven years if improvements are made at two years.
“This publication represents the longest follow-up of patients from a lumbar arthroplasty IDE Trial and proves without a doubt the safety and efficacy of lumbar disc arthroplasty,” said Kris Radcliff, MD (Rothman Orthopedic Institute, Philadelphia Pennsylvania). “I am proud to offer my patients this technology as an alternative to fusion.”
“Aesculap continues to see significant benefits toward quality of life with the activL Artificial Disc. The latest evidence of patient outcomes from our randomized controlled trial demonstrates the long-term impact of the technology,” said Charles DiNardo, President of Aesculap Implant Systems. “We see first-hand the impact lumbar arthroplasty has in returning patients’ quality of life and are hopeful that the seven-year data presented in this publication will provide the long-term evidence needed to further improve access to patients with DDD.”
The full text can be found on the IJSS website (www.ijssurgery.com)
About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients' lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.