Last week saw the North American Spine Society (NASS) hold its 28th annual meeting in New Orleans. At the event Integra LifeSciences Holdings Corporation announced receipt of FDA 510(k) clearance for the Integra®Hollywood™ NanoMetalene™ Interbody Device (IBD). The company expects to begin a controlled market release in the U.S. later this year.
The IBD is used primarily in transforaminal lumbar interbody fusion (TLIF), a surgical procedure designed to help alleviate pain and nerve compression by fusing and stabilizing adjacent vertebrae in the lower back. IBDs are designed to help provide stability for spinal fusion after a diseased disc is surgically removed. They are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height, and are intended to allow fusion between vertebral bodies. The graft window in the device is packed with bone, creating an environment in which the vertebral bodies can fuse together.
The Hollywood NanoMetalene IBD is a rather clever concept. It is composed of PEEK-OPTIMA® polymer, which has undergone a proprietary high-energy, low temperature surface process that creates a titanium coating around the entire implant, including the graft window in the middle of the IBD. This process provides the surface benefits of titanium without compromising the mechanical and imaging benefits of PEEK-OPTIMA. The ultrathin NanoMetalene coating does not impair postoperative imaging, allowing surgeons to view the operative area and determine the extent of fusion of the vertebral bodies.
“We’re very excited to introduce our first-ever spinal implant incorporating NanoMetalene technology,” said Kirt Stephenson, President, U.S. Spine. “Surgeons prefer the surface characteristics of titanium and the mechanical properties and radiolucency of PEEK-OPTIMA, and the Hollywood NanoMetalene IBD offers a treatment option that incorporates both benefits into one device.”
Source: Integra Lifesciences, Globe Newswire