Integra LifeSciences Launches Atoll Occipital-Cervical-Thoracic System
PLAINSBORO, N.J., May 4, 2009 (GlobeNewswire via COMTEX News Network) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the launch of the Atoll(TM) Occipital-Cervical-Thoracic (OCT) System, a posterior cervical spinal fixation system. With the addition of the Atoll(TM) OCT System, Integra Spine now offers spinal fusion solutions throughout the entire spine, from occiput to sacrum.
The Atoll(TM) OCT System received 510(k) clearance from the United States Food and Drug Administration (FDA) to be marketed in the United States in late March and is currently available in limited release. Full product launch is expected mid-summer 2009.
Posterior cervical spinal fusion is growing in popularity. An estimated 51,000 procedures will be performed in the United States in 2009. Posterior cervical fusion refers to stabilization of the cervical spine (neck) through various instrumentation techniques. Such procedures may be necessary following vertebral neck fractures, correction of cervical instability, cervical deformities, along with tumor resections, or to aid prior failed anterior fusions.
During a posterior cervical fusion procedure, titanium rods, plates, hooks and screws are used in combination to hold multiple levels of the cervical spine together. These components act as an internal brace to stabilize the structure sufficiently to allow for the progression of boney fusion.
"Not all spinal implant manufacturers are able to state they provide solutions from occiput to sacrum. This is part of our strategic focus by offering comprehensive spinal solutions," said Randy Theken, President of Integra Spine. "Just four years ago we had four spinal systems and now we offer fourteen. This helps our distributor partners by enabling them to offer full line spinal fusion solutions to surgeons."
The Atoll(TM) OCT System is distributed through the Integra Spine independent distributor network. Integra Spine is a leading provider of fusion implants and orthobiologics used in spinal surgery and is actively developing spinal motion preservation devices. For more information visit www.integraspine.com.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development, manufacturing, and marketing of clinically relevant, innovative, and cost-effective surgical implants and medical instruments. Integra's products, used primarily in neurosurgery, orthopedics and general surgery, are used to treat millions of patients every year. The company's headquarters are in Plainsboro, New Jersey, and it has research and manufacturing facilities throughout the world. For more information visit www.integra-ls.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 future use of the Atoll(TM) OCT System. 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 physicians to use these products may affect the prospects for their use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Risk Factors" included in section IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2008 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
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SOURCE: Integra LifeSciences Holdings Corp.
Integra LifeSciences Holdings Corporation
Gianna Sabella, Director of Corporate Communications
(609) 936-2389
gsabella@integra-LS.com
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