New Data Released for Luna Expandable ALIF Cage

Santa Clara, California-based Benvenue Medical, Inc. has released new 12-month clinical data for its Luna expandable cage for lumbar interbody fusion.

Richard G. Fessler, M.D., Ph.D. of Rush University, led the study and presented his results in a paper titled, “Biomechanical and Minimum One Year Clinical Results of a Novel 3-D Expandable Cage for Lumbar Interbody Fusion,” at the annual meeting of the North American Spine Society.

For the study, Dr. Fessler collected data from 47 consecutive MIS TLIF patients and found that lordosis was maintained or improved equally between the Luna lordotic cage and parallel cages. Dr. Fessler also reported that back pain and leg pain were equally relieved for both cages and that the patients in the study achieved a fusion rate of 95%.

Fessler reported that patient outcomes were improved as compared to their pre-operative condition, that disc height appeared to be restored as was foraminal height. According to Fessler, these 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 Fessler’s biomechanical data, he reported that the TLIF delivery of the Luna cage performed better in reducing intervertebral motion than the ALIF control cage.

“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.”

“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.”

Asked about the decrease in the ODI [Oswestry Disability Index] scores, Rob Weigle told OTW, “In the lordotic cases, the median was lowered from 32 to 12; in the parallel cases, the median was lowered from 30 to 16.”

“There is a clear need for technology that allows physicians to provide cost-effective, minimally invasive lumbar fusion procedures to patients, with the goal of improving overall quality of life and reducing pain. Together with our Orbit discectomy tools, we have developed a solution that offers surgeons a larger implant footprint via a minimally invasive approach. We believe this combination of products will change the future of minimally invasive lumbar fusion not only in the hospital but also in the ASC [ambulatory surgery center] setting.”