PLAINSBORO, N.J., March 6, 2008 (PRIME NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the introduction of the Large Qwix(TM) Fixation and Positioning Screw System. The Large Qwix(TM) system has received clearance to be marketed in the United States from the United States Food and Drug Administration (FDA) and a CE Mark Certification in the European Union, and will be featured at the 75th Annual American Academy of Orthopedic Surgeons (AAOS) Meeting this week.
The Large Qwix(TM) System is designed for correction and fixation of osteotomies, a surgical procedure where a bone is cut to shorten, lengthen, or change its alignment, and fractures of the mid and hind foot. The fixation screws employ self-drilling and self-tapping flutes on the shaft and head for quick and reliable insertion. Other Large Qwix(TM) fixation screw features include variable lags designed specifically for compression in extremity fixation, a cannulated shaft for insertion over a guide wire, a headless design for complete intraosseous fixation, and color coded instrumentation. The Large Qwix(TM) positioning screw employs a fully threaded headless design and is used for additional fixation across osteotomy or fracture sites when no additional compression is desired. Both the fixation and positioning screws are available in 5.5mm and 7.5mm diameters and are manufactured from titanium alloy.
"The Large Qwix(TM) system provides a self-drilling and self-tapping option for mid and hind foot procedures. The combination of the Large Qwix(TM) screws with the existing 3mm and 4.3mm Qwix(TM) screws and the Bold(R) screw gives Integra's extremity sales organization a comprehensive line of cannulated screws for lower extremity fixation," said John Barrett, Integra's Vice President of Marketing for Extremity Reconstruction.
Extremity fixation is an increasingly large segment of the orthopedic market. It is estimated that more than 400,000 extremity fusion and osteotomy procedures will be performed in United States in 2008. (Source: Hospital and diagnosis data from the Ortho FactBook(TM) 5th Edition, published April 2005 by Knowledge Enterprises).
The Extremity Reconstruction field sales organization, consisting of approximately 80 sales specialists, will sell the Large Qwix(TM) System. This sales force focuses on the areas of lower extremity fixation, upper extremity fixation, wound repair, tendon protection, and peripheral nerve repair/protection.
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. The company's products are used to treat millions of patients every year, primarily in neurosurgery, extremity reconstruction, orthopedics, and general surgery. Integra's headquarters are in Plainsboro, New Jersey, and it has research and manufacturing facilities throughout the world. 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 Large Qwix(TM) Fixation and Positioning Screw 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 this product may affect the prospects for its 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, 2006 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
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