The potential of disc replacement, especially in outpatient settings, will become stronger with regulatory approval for new innovation, Steven Girdler, MD, said.
Dr. Girdler, of Newport Beach, Calif.-based DISC Surgery Center, spoke with Becker’s about what’s in store for disc replacement.
Note: This conversation was lightly edited for clarity.
Question: What do you think will be the next big development in disc replacement innovation?
Dr. Steven Girdler: Part of why we’re interested in doing these studies, mine being about the disc replacements, is to look at cases that may be fringe or not FDA approved. A small subset of the patients in my study got three level disc replacements that aren’t FDA approved. This is fully off-label and disclosed to all patients, and yet, there are a small subset of patients that would benefit from them.
We’re all hoping to provide long-term data with clinical outcomes before and after surgery that show these patients do very well and to show that we can do this complex surgery in an outpatient setting. Then we want to take that data to the FDA and prompt approval that doesn’t currently exist like three-level disc replacement in the subset of patients where it would be beneficial. So that’s one thing, is sort of expanding the boundaries of what is traditionally accepted in the world of disc replacement.
The FDA also has very rigid restrictions on which implants can be used for one or multiple level disc replacement. I think within the next six months, and certainly by next year, is for those two level indications to be expanded to a few of the other disc replacement models available.
