The ActivL is designed as an alternative to spinal fusion surgery, the Center Valley, Pa.-based company said, and is the 1st lumbar disc with a mobile ultra high molecular weight polyethylene core that supports both controlled translational and rotational movement.
“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 1st medical device company in 10 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,” president Chuck DiNardo said in a press release.
During the investigational device exemption trial, the ActivL disc demonstrated non-inferiority, and had a greater success rate than control devices, the company said.
“The ActivL IDE Trial outcomes add to the extensive body of evidence supporting the use of lumbar total disc replacement in risk stratified patients. 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,” co-lead investigator Dr. Rolando Garcia, of Florida’s Aventura Medical Center, said in prepared remarks.
“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. 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,” co-lead investigator Dr. James Yue, of Yale Medical Center, said in a prepared statement.