By Fink Densford
B. Braun Medical subsidiary Aesculap said today that it won FDA approval for its ActivL artificial disc indicated for the treatment of 1-level lumbar degenerative disc disease.
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.
