PLAINSBORO, N.J., Oct. 9, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) 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 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."
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.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. For more information, please visit www.integralife.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading "Risk Factors" included in Item IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2012 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
PEEK-OPTIMA is a registered trademark of Invibio Limited.
1 Testing data on file