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Devices Neurosurgery FDA

 News Release - April 4, 2014

Integra LifeSciences Announces Camino(R) Flex Ventricular Catheter Receives FDA Clearance for Use With MRI Scans

PLAINSBORO, N.J., April 4, 2014 -- (Healthcare Sales & Marketing Network) -- Integra LifeSciences Holdings Corporation (IART) today announced that the Camino(R) Flex Ventricular Catheter has received clearance from the United States Food and Drug Administration (FDA) for use with magnetic resonance imaging (MRI). The Camino Flex Ventricular Catheter is an advanced, tunneled ventricular catheter that is MR conditional at 1.5 and 3.0 T, with a sensor designed to measure directly at the source, and is used with Integra's next-generation Camino(R) Monitor, which debuted in 2013. Integra is a leading provider of advanced intracranial pressure monitoring (ICP) systems. Over 800 centers in the United States use the Camino platform for conditions that cause an elevated intracranial pressure, including traumatic brain injury, subarachnoid hemorrhage, and stroke.

"We are very pleased that our Camino Flex Ventricular Catheter is approved for MRI scans," said Peter Ligotti, Integra's Vice President of Marketing, Neurosurgery. "MRI scans for patients receiving neuromonitoring are becoming more prevalent, and patients implanted with Integra's Camino Flex Ventricular Catheter can now safely undergo MRI scans without the need to remove the catheter. This is especially beneficial for neuro patients whose management includes both CSF drainage and follow-up MRI."

When coupled with the Camino Monitor, the Camino Flex Ventricular Catheter provides clinicians access to a truly advanced system for the diagnosis and treatment of compromised neurological conditions. Unlike other tunneled ventricular catheters that depend upon CSF flow to measure ICP, the Camino Flex Ventricular Catheter continuously monitors ICP independently in the ventricles, even when CSF flow cannot be established or the catheter is occluded by a blood clot. A multilumen design also allows for simultaneous CSF drainage and ICP monitoring, providing a continuous measurement of ICP and waveforms. The Camino Monitor is a modernized platform designed to incorporate both tunneled and bolted advanced monitoring technologies, which monitor ICP in either the parenchyma or ventricle space. Easily portable and ergonomically designed, the monitor integrates strain gauge and fiber optic monitoring technologies. It features up to five days of patient ICP data trending, and has a unique, large and highly visible touchscreen interface.

Integra, a leading provider of implants, devices, instruments, and systems used in neurosurgery, neuromonitoring, neuro-trauma, and related critical care, delivers a full line of neurocritical care solutions with its portfolio of cranial access kits, CSF drainage systems, including the AccuDrain(R) External CSF Drainage System and LimiTorr(TM) Volume Limiting CSF Drainage System, and the Licox(R) Brain Tissue Oxygen Monitoring platform.

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

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, 2013 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Source: Integra LifeSciences

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