Integra LifeSciences Now Offers Zero-Profile, Stand-Alone Interbody Devices for Neck and Lumbar Fixation Procedures
PLAINSBORO, N.J., Oct. 24, 2012 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the full U.S. market release of the Integra® Complete Cervical Intervertebral Body Fusion Device (IBD), expanding Integra's spine product portfolio with the addition of a zero-profile, stand-alone IBD for anterior cervical decompression and fusion (ACDF) procedures. The Integra® Complete Cervical IBD has received 510(k) clearance from the United States Food & Drug Administration (FDA), and is designed to help provide stability for spinal fusion after a diseased cervical disc is surgically removed.
"The stand-alone IBD option is a growing market segment, and Integra is now well positioned within this market with solutions for both the cervical and lumbar regions of the spine," said Kirt Stephenson, President, U.S. Spine.
Traditionally, surgeons use a supplemental fixation plate to help hold an IBD in place. However, the Integra® Complete Cervical IBD features the benefit of a zero-profile, stand-alone design by utilizing two screws to help secure the IBD in its functional position, eliminating the need for a supplemental fixation plate. The Integra® Complete Cervical IBD System is a natural complement to the Zuma-C™ stand-alone integrated plate and cervical spacer system. Its design is based on the Vu aPOD™ Prime platform, utilizing one cephalad and one caudal screw to anchor the implant to the vertebral bodies, and offers a wide variety of implant sizes, combined with a comprehensive set of instrumentation.
Integra, a leading provider of fusion implants and orthobiologics used in spinal surgery, now offers stand-alone IBDs for both cervical and lumbar procedures. Stand-alone cervical solutions include the Complete Cervical IBD and the Zuma-C™ Anterior Cervical Fixation System, and lumbar stand-alone solutions include the Vu aPODTM Prime and the Zuma™ Stand-alone Anterior Lumbar Fixation System. Integra's IBD portfolio also includes the Hollywood™ IBD, Pacifica™ IBD, Vu cPOD™ IBD, Vu ePOD™ IBD, Vu LPOD™ IBD Redondo™ IBD, and Ventura™ IBD.
Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurgery, spine, 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, 2011 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: Gianna Sabella
Director, Corporate Communications
(609) 936-2389
gianna.sabella@integralife.com