Benvenue Medical, Inc. has announced that its expandable fusion device is expanding the company’s spine portfolio. The Luna 360 Interbody Fusion System, made from PEEK-OPTIMA, has received 510(k) clearance from the FDA for spinal fusion treatment of symptomatic degenerative disc disease (DDD).
Benvenue Medical Receives 510(k)
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According to the December 2, 2014 news release, the Luna 360 System is a “minimally invasive lumbar interbody fusion…device that incorporates Benvenue Medical’s proprietary implant technology. The…implant provides spine surgeons a small delivery cannula for posterior access, and the implant expands to a large footprint. The Luna 360 Implant involves a four-step process: deploying through a posterior approach; expanding in-situ and vertically within the disc space to restore disc height; then filling the implant, allowing surgeons to insert and maximize the volume of autologous bone graft post-Luna expansion, and lock the implant, securing the 360 degree construct.”
“The Luna 360 expandable implant brings the benefits of ALIF surgery and cage size with a controlled and guided TLIF delivery, and addresses many of the deficiencies of current expandable interbody fusion devices, ” said Sandeep Kunwar, M.D., FACS, neurosurgeon at the California Center for Minimally Invasive Brain & Spine Surgery and associate professor of neurological surgery at the University of California, San Francisco, in the news release. “This minimally invasive approach enables us to stabilize the spine and restore the native anatomy.”
As indicated by the company, the Luna 360 System includes the least invasive implant currently available, which helps to minimize tissue retraction and protects the neural structures.
“Benvenue Medical is committed to pioneering new techniques, leveraging our proprietary material science and setting new standards for improved patient outcomes in spinal repair, ” said Robert Weigle, CEO of Benvenue Medical, Inc. “The Luna 360 Interbody Fusion System is the newest example of this commitment, as the next generation, least invasive approach in spinal fusion procedures.”
Weigle told OTW, “Benvenue Medical is planning a full commercial launch for the Luna 360 System and we’ll have more details as they become available.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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