Benvenue Reports First U.S. Surgery Using the Luna 360 Interbody Fusion System

Santa Clara, Calif.-based Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, reported the first spinal fusion patient in the United States has been treated with the company’s Luna 360 Interbody Fusion System.

The company received U.S. Food and Drug Administration 510(k) clearance in December.

The surgery was performed at Washington Hospital in Fremont, Calif., by Sandeep Kunwar, M.D., a neurosurgeon at Washington Township Medical Foundation and an associate clinical professor of Neurological Surgery at the University of California at San Francisco.

Spinal fusion is a procedure that fuses, or joins, two or more vertebrae to treat low back pain from degenerated discs. One of the most common causes of low back pain, degenerated discs often cause symptoms of pain and sometimes radiating weakness or numbness in the legs. The fusion is designed to eliminate motion in that fused segment of the spine, thereby decreasing or eliminating the back pain.

“The Luna 360 is an important advancement in spinal fusion,” said Kunwar. “Its ability to expand in three dimensions allows me to place a large, supporting spacer into the spine while utilizing a very small incision. This minimizes nerve retraction and allows patients to recover more quickly. Incorporating this elegant technology into our spine center is an example of our commitment to providing patients with access to the most advanced treatments available today.”

According to the company, the Luna 360 is different from other spinal fusion devices and presents several benefits for both spine surgeons and patients:

• Luna 360 can be expanded after being placed within the disc space. This mitigates the need to impact a large spacer into the collapsed space, which can damage the vertebral body;
• Luna 360 is designed to be inserted in a linear, elongated state to minimize tissue retraction and protect the neural structures;
• Once positioned inside the disc, the implant expands in three dimensions to create a large footprint for stable fixation; and
• Bone grafting is optimized, since graft material is placed into the implant after expansion.

“The Luna 360 Interbody Fusion System reflects Benvenue Medical’s commitment to developing technologies that improve patient outcomes in spinal repair,” said Robert Weigle, CEO of Benvenue Medical. “Washington Hospital’s early adoption of the Luna System demonstrates that hospitals and surgeons are actively seeking out less invasive treatment options for degenerative disc disease.”

The Luna 360 System features a small-profile polyether ether ketone (PEEK) implant designed to expand in three dimensions within the disc space, allowing surgeons to restore height via a posterior approach while providing the stable fixation of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 360 Implant is delivered through a small diameter cannula into the disc space and then expanded with the insertion of a middle section. When the cannula is removed, bone graft is placed in the middle of the implant and the implant is locked in place with a locking wire.

Founded in 2004, Benvenue Medical is venture backed.