Benvenue Medical, Inc., a developer of minimally invasive expandable implant solutions for spine repair, today announced that positive interim results of a retrospective analysis of its Luna® 3D Multi-Expandable Interbody Fusion System will be presented at the Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves (Spine Summit) taking place March 14-17 in Orlando. The single center minimally invasive study evaluated the safety and efficacy of the Luna device when placed from a standard minimally invasive transforaminal lumbar interbody fusion (TLIF) approach.
Richard Fessler, M.D., study investigator and professor of neurosurgery at Rush University. said, “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.” He notes, “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.”
The retrospective analysis evaluated 31 patients treated with the Luna 3D System who had at least six months of post-operative follow up. All but one patient experienced improvement in pain scores from baseline, and disability scores improved for all patients. When present, spondylolisthesis was reduced significantly. No instances of graft subsidence or hardware failure occurred.
“These safety and efficacy results lay the groundwork for our ongoing evolution of the Luna 3D Interbody Fusion System,” said Robert K. Weigle, CEO of Benvenue Medical. “We are currently developing a 2.0 version of the system that leverages our original platform and vision, improves the user experience and is designed to be minimally invasive to improve outcomes for patients and for use in the growing, emerging outpatient ambulatory spinal surgery center setting. We expect to submit for FDA clearance on Luna 2.0 later this year.”
“Minimally invasive spinal surgery and procedures in the outpatient setting are forecasted to grow considerably in the near term, and we see Luna as an important technological advancement in advancing patient care, quality and economic outcomes for the patient suffering from degenerative disc disease,” said Luke Düster, managing director and partner at CRG, an investor in Benvenue Medical.
Dr. Fessler will present the analysis, “Minimally invasive transforaminal lumbar interbody fusion with a multi-directional expandable device,” in the sponsored What’s New 2 session on Thursday, March 15, from 2:52-3:02 p.m. Benvenue is also exhibiting at Spine Summit in booth #311.