Luna® 360 Interbody Fusion System from Benvenue Medical Receives FDA Clearance
Luna® 360 Interbody Fusion System from Benvenue Medical Receives FDA Clearance Dec 2014
Implant Marks Benvenue Medical’s Entry into Expandable Lumbar Interbody Fusion Device Market
SANTA CLARA, Calif. – December 2, 2014 – Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced that the company’s Luna® 360 Interbody Fusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for spinal fusion treatment of symptomatic degenerative disc disease (DDD). The clearance represents an important expansion of Benvenue Medical’s spine product portfolio beyond the Kiva® VCF Treatment System 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 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.”
The Luna 360 System includes the least invasive implant currently available, which 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.
“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.”
About the Luna® 360 Interbody Fusion System
The Luna 360 Interbody Fusion System is designed to provide the least minimally invasive approach to lumbar spinal fusion while providing spine surgeons control and flexibility in implantation. The Luna 360 System features a small profile PEEK implant designed to expand in-situ within the disc space, allowing the surgeon to restore height using a well-established posterior approach while providing the stable fixation via a larger construct that more often is achieved using an anterior approach. After a discectomy is performed, the Luna 360 Implant is delivered through a small diameter cannula into the disc space, via a single incision in a predetermined arcuate shape. It is expanded with the insertion of a middle section. When the cannula is removed, bone graft is placed in the middle of the implant. The implant is then locked in place with a locking wire.
The Luna 360 Interbody Fusion System consists of a Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 Interbody Fusion System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 Interbody Fusion System is to be used with supplemental fixation.
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by InterWest Partners, Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.