NASS News: Luna Device Demonstrates Improved Patient Outcomes, Decreased Back and Leg Pain

Benvenue Medical Inc., a developer of minimally invasive surgery (MIS) expandable implant solutions for lumbar fusions, has announced data demonstrating clinical results of improved relief of back pain and leg pain, as well as lowered Oswestry Disability Index (ODI) scores at 12 months post-op with its Luna product. Richard G. Fessler, M.D., Ph.D. of Rush University, presented the data from the study titled “Biomechanical and Minimum One Year Clinical Results of a Novel 3-D Expandable Cage for Lumbar Interbody Fusion,” on Sept. 25 at the Innovative Technology Presentations event at the North American Spine Society’s 34th Annual Meeting.
 
Dr. Fessler’s single center data of 47 consecutive MIS TLIF patients showed lordosis was maintained or improved equally with the Luna lordotic and parallel cages, and back pain and leg pain were equally relieved for both cages, including a fusion rate of 95 percent. Patient outcomes were improved, appearing to be due to restoration of disc space height and therefore, foraminal height. The findings suggest that the larger footprint of the Luna expandable Transforaminal Lumbar Interbody Fusion (TLIF) cage combined with the preservation of the anterior soft-tissue tension band may provide a better biomechanical fusion environment, combining the advantages of the traditional Anterior Lumbar Interbody Fusion (ALIF) and TLIF approaches. In a separate independent analysis of biomechanical data, the TLIF delivery of the Luna cage performed better in reducing intervertebral motion than the ALIF control cage.¹
 
“The Luna data shows an excellent correction of disc space height and foraminal height,” said Dr. Fessler. “There was a strong correlation between that correction and clinical outcomes. It’s the most exciting interbody device that I’ve seen in my career—it can be put in through a TLIF exposure but expands into ALIF coverage. It achieves both of my surgical goals of being minimally invasive and offering maximal coverage.”
 
Luna is a small multi-expandable interbody fusion device that combines ALIF principles with a controlled posterior approach that is designed to provide anterior column stability, strength and fusion support in patients with symptomatic degenerative disc disease (DDD).
 
“The results from this study confirm that our Luna interbody cage provides improved outcomes for patients with degenerative disc disease,” said Robert K. Weigle, CEO of Benvenue Medical. “We are thrilled to offer an interbody cage device that utilizes the smallest incision while providing the largest implant footprint designed to afford surgeons a large graft chamber to facilitate fusion success, maximum height restoration, optimized sagittal balance, and minimal subsidence with consistent deployment.”
 
Benvenue Medical will showcase the Luna XD and the company’s suite of products at their booth #2516 at The North American Spine Society 34th Annual Meeting in Chicago on September 25-28, 2019.
 
Reference
¹ Conti M, Voronov L, Carandang G, Havey R, Wojewnik B, Patwardhan A. Biomechanics of an expandable lumbar interbody fusion cage deployed through transforaminal approach. International Journal of Spine Surgery. Aug 2017; Vol 11 issue 4; 193 – 200.