Healthcare Industry News: spinal IBD
News Release - January 9, 2009
Integra LifeSciences Launches a Series of PEEK-Optima(R) Interbody Spinal ImplantsPLAINSBORO, N.J., Jan. 9, 2009 -- (Healthcare Sales & Marketing Network) -- Integra LifeSciences Holdings Corporation (NasdaqGS:IART ) announced today the launch of a series of intervertebral body fusion devices (IBD), the Vu e-POD(TM) and Vu L-POD(TM) through the newly formed Integra Spine.
The Vu e-POD and Vu L-POD received clearance from the United States Food and Drug Administration (FDA) to be marketed as a spinal IBD. Prior to receiving the IBD status, the devices were cleared by the FDA as spinal vertebral body replacement devices (VBR).
The dual classification of the Vu e-POD and the Vu L-POD gives the surgeon a broader range of usages. As an IBD, they are used as an adjunct to fusion in patients with degenerative disc disease at one or two contiguous levels (L2-S1). As a VBR, they may be used to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (T1-L5).
The Vu e-POD's unique technique of distraction during insertion reduces the amount of steps and instruments required to perform the surgery. This contributes to decreasing the length of time needed to perform the procedure. (U.S. Patent No. 6,290,724 licensed from NuVasive, Inc.)
Randy Theken, President, Integra Spine, states, ``The Vu e-POD all-in-one insertion and distraction technique gives Integra Spine a true competitive advantage. It leads to benefits for both the surgeon and patient. No longer is a second instrument required to distract the disc space. It is accomplished through a simple rotation technique performed after inserting the device.''
IBDs are small hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and to allow fusion between vertebral bodies. These devices relieve pressure on the nerves and associated back pain by maintaining the native disc space height and by providing positive mechanical stabilization for fusion. The graft window allows natural bone growth to occur through the graft and form a strong vertebral union along with the implant. The IBD market for 2008 is estimated at $1,045M with a CAGR of 3.0% through 2012 (Millennium Research Group, 2007).
The Vu e-POD and Vu L-POD are distributed through the Integra Spine independent distributor network. Integra Spine is a leading provider of fusion implants, motion preservation devices and orthobiologics used in spinal surgery. Integra Spine provides a comprehensive product line from occiput to sacrum. Visit http://www.integraspine.com for more information.
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 http://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 Vu e-POD and Vu L-POD. 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, 2007 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.
Source: Integra LifeSciences
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