Benvenue Medical: Positive Results for Luna Fusion Device

Santa Clara, California-based Benvenue Medical, Inc. has announced positive interim results of a retrospective analysis of its Luna 3D Multi-Expandable Interbody Fusion System. The study, which included 31 patients, evaluated the safety and efficacy of the Luna device when placed from a standard minimally invasive transforaminal lumbar interbody fusion (TLIF) approach.

“The brilliance of Luna is its ability to engage the disc space through a minuscule annulotomy, and then expand to cover the greatest expanse of any intervertebral device available,” said Richard G. Fessler, M.D., study investigator and professor of neurosurgery at Rush University. “In our analysis, minimally invasive TLIF placement of the Luna device was shown to be safe and effective, improving pain and disability scores as well as consistently restoring disc height, reducing spondylolisthesis and increasing lumbar lordosis.”

“All but one patient experienced improvement in pain scores from baseline, and disability scores improved for all patients. When present, spondylolisthesis was reduced significantly,” read the company news release. “No instances of graft subsidence or hardware failure occurred.”

Dr. Fessler told OTW, “As an academic surgeon, I study everything I do. When I changed from my previous MIS [minimally invasive surgery] interbody cage to Luna, it was natural to begin studying it immediately. Because of the design of the cage, I went in with the hypothesis that I would see a larger footprint, resistance to migration and subsidence with an increased fusion rate.”

“To date, fusion is occurring faster than I’m used to. My fusion rate is close to 100% in all patients who are at least six months out from surgery (n=44 patients). Previously this would have taken a year or more to observe radiographically.”

“It is now possible to achieve the surface area coverage that we normally get through an ALIF [anterior lumbar interbody fusion] approach through TLIF. We had not been able to do that before. We used to have to go through the abdomen to get that same kind of clinical outcome, but it’s very invasive for patients and is riskier given exposure to the great vessels.”

“Having done interbody fusions for the past 30 years, this is the most impressive cage that I’ve worked with. Whereas fusion would have previously taken a year to a year and a half, we can now achieve that in six months through a less invasive approach, and no evidence of subsidence.”