Last December we covered the news that Benvenue Medical had gained FDA clearance for its minimally invasive Luna® 360 Interbody Spinal Fusion System. Now the company is reporting first post-clearance clinical use.
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. Spinal fusion is a procedure that fuses, or joins, two or more vertebrae to treat low back pain from these degenerated discs. The fusion is designed to eliminate motion in that fused segment of the spine, thereby decreasing or eliminating the back pain.
It’s been a couple of years since we first encountered Benvenue Medical, Inc., developer of minimally invasive solutions for spine repair, most recently with its Luna® 360 Interbody Fusion System that offers a unique approach to the therapy.
The Luna 360 System features a small profile 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.
Unlike other systems, Luna 360 mitigates the need to impact a large spacer into the collapsed space, which can damage the vertebral body. Its method of insertion means it minimizes the need for tissue retraction and protects the neural structures. Then, once positioned inside the disc, the implant expands in three dimensions to create a large footprint for stable fixation. And when the device is confirmed in situ, bone grafting is optimized, since graft material is placed into the implant after expansion.
The newly reported surgery was performed at Washington Hospital in Fremont, California, by Sandeep Kunwar, MD, FACS, a neurosurgeon at Washington Township Medical Foundation and an associate clinical professor of Neurological Surgery at UCSF.
“The Luna 360 is an important advancement in spinal fusion,” said Dr. 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.”
“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, Inc. “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.”
Source: Benvenue Medical, Inc.