FDA Clears Benvenue’s Luna® 360 Interbody Fusion System

Developer of minimally invasive solutions for spine repair, Benvenue Medical, Inc., has gained U.S. FDA 510(k) clearance for its Luna® 360 Interbody Fusion System.The device is indicated for spinal fusion treatment of symptomatic degenerative disc disease (DDD).

Background

Best known for its Kiva® VCF Treatment System, the Luna 360 system takes Benvenue Medical ’s spine product portfolio into the $3.2 billion U.S. market for expandable interbody fusion devices.

The Luna 360 System is a novel, minimally invasive lumbar interbody fusion device for DDD that incorporates Benvenue Medical’s proprietary implant technology. The expandable 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 System includes the least invasive implant currently available, which the company claims helps to minimize tissue retraction and protects the neural structures. It is made from PEEK-OPTIMA®, a biocompatible polymer that is widely used and well accepted as a spinal implant, and is also used in the Kiva VCF Treatment System.

Physician comments

“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, MD, 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. “This minimally invasive approach enables us to stabilize the spine and restore the native anatomy.”

Company comments

“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.”

Source: Benvenue Medical, Inc.

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