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Integra LifeSciences Introduces the
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An Innovative Solution for Tibiotalocalcaneal
Fusion
News Release - Source: Integra LifeSciences Holdings Corp.
Integra LifeSciences Introduces the Panta Arthrodesis Nail
PLAINSBORO, N.J., March 22, 2006 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the release of the Panta(R) Arthrodesis Nail, an innovative solution for tibiotalocalcaneal fusion. The Panta Nail has received clearance from the Food and Drug Administration (FDA) in the United States and a CE Mark Certification in the European Union. Integra will feature the product at the American Association of Orthopedic Surgeons in Chicago this week.
The unique Panta Nail compression device allows the application of up to 12mm of bilateral axial compression across the ankle and subtalar joints. Compression is applied equally on the medial and lateral sides of the construct to avoid the introduction of torque and coronal tilt. The ideal amount of compression is dialed in using the wheel mechanism and is locked in by simply placing the tibial screws.
The Panta Nail is manufactured from titanium alloy and is available in multiple lengths and diameters to accommodate anatomic variation. The calcaneus screws are oriented in the anterior/posterior plane for increased purchase. The tibial screws are oriented perpendicular (medial/lateral) to the calcaneus screws for increased rotational stability. An optional talus screw may be placed if desired. Fully threaded 5mm screws are available in 20 to 110mm lengths.
The Panta Nail instrumentation is color coded to simplify the surgical technique. The drill guides and sleeves and drills corresponding to the tibia, calcaneus and talar screws are color matched to the corresponding insertion points on the targeting/compression device.
"We have been fortunate to collaborate with Dr. James Brodsky, current President of the American Orthopedic Foot and Ankle Society, in the clinical design of the Panta Nail," said Deborah Leonetti, Integra's Senior Vice President of Marketing.
"The Panta Nail was designed with a unique targeting device that will allow the surgeon to control the compression that is so important in these cases," said Dr. Brodsky. "We have been extremely happy with the early results of the initial clinical cases on which we have used the Panta Nail."
Dr. Brodsky and Professor Beat Hintermann, MD, from the University of Basal, Switzerland, will review the design rationale and their initial clinical results at a breakfast meeting at the AAOS in Chicago on Friday, March 24th.
Ankle fusion procedures represent a significant segment of the foot and ankle reconstructive market. Experts estimate that approximately 15,000 ankle fusion procedures will be performed in the United States in 2006.
The Panta Nail will be sold by the Integra Reconstructive Surgery sales organization. Integra Reconstructive Surgery provides devices for the correction and reconstruction of the foot and ankle as well as wound care products and peripheral nerve repair products. Integra Reconstructive Surgery's direct selling effort in the United States currently involves more than 50 professionals.
Integra LifeSciences Holdings Corporation is a diversified medical technology company that develops, manufactures, and markets medical devices for use in a variety of applications. The primary applications for our products are neurosurgery, reconstructive surgery and general surgery. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. Our corporate headquarters are in Plainsboro, New Jersey, and we have research, manufacturing and distribution facilities located throughout the world. We have approximately 1,400 employees. Please visit our website at 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 use of the Panta Arthrodesis Nail. 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 the Panta Arthrodesis Nail may affect the prospects for its use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Factors That May Affect Our Future Performance" included in the Business section of Integra's Annual Report on Form 10-K for the year ended December 31, 2005 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: Integra LifeSciences Holdings
Corporation
John B. Henneman, III, Executive Vice President Chief Administrative Officer
(609) 936-2481 jhenneman@Integra-LS.com
Maria Platsis, Senior Director of Corporate Development and Investor
Relations
(609) 936-2333, mplatsis@Integra-LS.com
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