Integra Announces the Addition of a Low Profile Shunt to the OSVII Flow-Regulating Shunts
PLAINSBORO, N.J., Sep 22, 2008 (GlobeNewswire via COMTEX News Network) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the introduction of the OSVII Low Pro(TM) Valve, a low profile version of the OSVII(R) Flow-Controlled Hydrocephalus Valve. The OSVII Low Pro(TM) Valve will be featured at the 58th Annual Meeting of the Congress of Neurological Surgeons (CNS) in Orlando, Florida, September 20-25, 2008.
The Integra OSVII Low Pro(TM) Valve is an implantable shunt system used in the treatment of hydrocephalus. The system shunts cerebrospinal fluid (CSF) from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity or the heart's right atrium. The OSVII Low Pro(TM) Valve was designed with a lower profile to accommodate various patient populations including pediatric patients.
Integra's OSVII(R) Valves are self-adjusting and automatically adapt to the patient's changing needs without the need for programming. The flow-controlled valves represent a revolutionary advancement in the treatment of hydrocephalus, as they maintain a constant CSF flow rate, close to that of normal CSF production, therefore minimizing the risks of under or overdrainage. With three stages of operation, the OSVII(R) and OSVII Low Pro(TM) Valves act as a conventional differential pressure valve at very low pressures, but spend most of the time maintaining a CSF flow rate within a range of 18-30 ml/hour. In the event of sudden increases in intraventricular pressure, it has a third safety stage where it allows a higher flow rate until pressure is returned to a normal range.
"Integra is very pleased to introduce the new OSVII Low Pro Valve(TM), which offers physicians more shunt options and allows them to more accurately address the individual needs of their patients," said Brian Larkin, President of Integra NeuroSciences.
Hydrocephalus is most commonly treated by inserting a shunt into the ventricular system of the brain to divert the flow of cerebrospinal fluid out of the brain and through a pressure valve to maintain a normal level of cerebrospinal fluid within the ventricles. Each year there are 50,000 new implants and revision cases to treat hydrocephalus. The total U.S. market for hydrocephalus management is over $100 million.
Integra currently offers a diverse line of hydrocephalus management products, including the OSVII(R) and Integra NPH(TM) flow-controlled valves, Integra DP(TM) (formally Integra Hakim), Equi-Flow(TM), Novus(TM), LPVII(TM), Pudenz(TM) and H-V Lumbar Valves, as well as ventricular, lumbar, peritoneal and cardiac catheters.
The Integra NeuroSciences direct sales organization will sell the OSVII Low Pro(TM) Valve Systems. Integra NeuroSciences is a leading provider of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neuro-trauma, and related critical care. Integra NeuroSciences' direct selling effort in the United States and Europe involves more than 200 direct sales professionals. In all other markets, Integra NeuroSciences products are sold through a network of distributors.
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 cost-effective surgical implants and medical instruments. Integra's products, used primarily in neurosurgery, extremity reconstruction, 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 OSVII Low Pro(TM) Valve Systems and other hydrocephalus management products. 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.
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SOURCE: Integra LifeSciences Holdings Corp.
Integra LifeSciences Holdings Corporation John B. Henneman, III, Executive Vice President, Finance and Administration, and Chief Financial Officer (609) 936-2481 jhenneman@Integra-LS.com Gianna Sabella, Public Relations Manager (609) 936-2389 gsabella@intergra-LS.com
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