The US Food and Drug Administration (FDA) has granted 510(k) clearance for Benvenue Medical’s Luna 360 Interbody Fusion System.
It is designed for spinal fusion treatment of symptomatic degenerative disc disease (DDD).
FDA clearance represents an important expansion of the company’s spine product portfolio beyond the Kiva VCF Treatment System into the $3.2bn US market for expandable interbody fusion devices.
The system is designed for spinal fusion procedures in skeletally mature patients with DDD at one or two contiguous levels from L2-S1.
It includes a small profile PEEK implant designed to expand in-situ within the disc space, as well as a Luna 360 Implant and associated accessories.
California Center for Minimally Invasive Brain & Spine Surgery neurosurgeon Sandeep Kunwar said: "The Luna 360 expandable implant brings the benefits of anterior lumbar interbody fusion (ALIF) surgery and cage size with a controlled and guided TLIF delivery, and addresses many of the deficiencies of current expandable interbody fusion devices.
"This minimally invasive approach enables us to stabilise the spine and restore the native anatomy."
The lumbar interbody fusion device provides spine surgeons a small delivery cannula for posterior access and the implant expands to a large footprint.
Benvenue Medical CEO Robert Weigle said: "Benvenue Medical is committed to pioneering new techniques, leveraging our proprietary material science and setting new standards for improved patient outcomes in spinal repair.
"The Luna 360 Interbody Fusion System is the newest example of this commitment, as the next generation least invasive approach in spinal fusion procedures."
The system was made using a biocompatible polymer Peek-Optima, and is the least invasive implant currently available that helps to minimise tissue retraction and protects neural structures.