UPDATE: Integra Wins 510(K) Clearance for Hollywood Nanometalene IBD

Integra LifeSciences Holdings Corporation

today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Integra® HollywoodTM NanoMetaleneTM Interbody Device (IBD), and 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. Integra's newest IBD will be featured at the North American Spine Society (NASS) 28th annual meeting, October 9 – 12, 2013, in New Orleans, Louisiana. The Hollywood NanoMetalene IBD 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-OPTIMA1. 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