Healthcare Industry News: intervertebral body fusion
News Release - November 2, 2011
Integra LifeSciences Launches a Zero-Profile, Stand-Alone Interbody Device for Neck SurgeryFewer Implants and Steps Required to Perform an Anterior Cervical Procedure
PLAINSBORO, N.J., Nov. 2, 2011 -- (Healthcare Sales & Marketing Network) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART ) today announced the U.S. controlled market release of the Integra(TM) Complete Cervical intervertebral body fusion Device (IBD), expanding Integra's spine product portfolio with the addition of its first zero-profile, stand-alone IBD cervical solution. The IntegraTM 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.
IBDs are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and allow fusion between vertebral bodies. These devices relieve pressure on the nerves and provide positive mechanical stabilization of the vertebrae. The graft window in the device is packed with bone and provides an environment in which natural bone growth can occur, which then enables fusion of the vertebral segments.
Traditionally, surgeons use a supplemental fixation plate to help hold the IBD in place. However, the Integra(TM) Complete Cervical IBD features the benefit of a zero-profile design by utilizing two screws to help secure the IBD in its functional position, eliminating the need for a supplemental fixation plate. "This concept is ideal for a cervical discectomy as it may lead to less tissue dissection and retraction. The zero-profile design of the Complete Cervical IBD makes the device more tissue friendly," said Abid Qureshi, MD.
Integra(TM) Complete Cervical IBD's design is based on the Vu aPOD(TM) Prime platform. Offering a wide variety of implant sizes, combined with a comprehensive set of instrumentation, Integra(TM) Complete Cervical IBD is a less invasive alternative to the traditional anterior plate with interbody construct used for anterior cervical fusion procedures.
"No one device can meet every anatomical or procedural need. Our expanded product line allows us to offer surgeons a wider variety of cervical solutions, including PEEK interbody fusion solutions with our Vu cPOD(TM) and Cambria(TM) devices, an integrated plate and interbody solution with our Zuma-C(TM) system and now, a zero-profile, stand-alone solution," said Kirt Stephenson, Integra's President, U.S. Spine.
Integra is a leading provider of fusion implants and orthobiologics used in spinal surgery. Integra's Cervical portfolio also includes the Manta Ray(TM) Anterior Cervical Plate, Cordant(TM) Anterior Cervical Plate, Sonoma(TM) Anterior Cervical Plate, Atoll(TM) Posterior Cervical System, Sierra(TM) Posterior Fusion System and Vu cPOD(TM) intervertebral body fusion Device, Cambria(TM) Intervertebral Body Device, and the Capistrano(TM) Allograft Spacer.
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, 2010 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
Source: Integra LifeSciences
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