Positive interim results of a retrospective analysis of the Luna 3D multi-expandable interbody fusion system were announced by Benvenue Medical at the Annual Meeting of the AANS/ CNS Section on Disorders of the Spine and Peripheral Nerves (14—17 March, Orlando, USA).
The single centre 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.
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.
Richard Fessler (Rush University, Chicago, USA), study investigator, comments, “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. 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 Luna 3D interbody fusion system is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space. A press release explains how the device expands first in footprint, second in height and third in lordosis, allowing surgeons to restore sagittal balance and height via a minimally invasive posterior approach, while providing the stability of a larger construct more often associated with an anterior approach. Following a discectomy, the Luna 3D implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, the device is then expanded in height and lordosis with the insertion of a middle section. When the cannula is removed, a large volume of bone graft is placed in the middle of the implant to facilitate an interbody fusion.
“These safety and efficacy results lay the groundwork for our ongoing evolution of the Luna 3D Interbody Fusion System,” says 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.”
Luke Düster, managing director and partner at CRG (an investor in Benvenue Medical), states, “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.