Integra LifeSciences Announces the Release of the PANTA XL Arthrodesis Nail
PLAINSBORO, N.J., Aug 7, 2009 (GlobeNewswire via COMTEX News Network) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the release of the Panta(R) XL Arthrodesis Nail, a solution for tibiotalocalcaneal (TTC) arthrodesis. The Panta(R) XL Nail has received clearance from the U.S. Food and Drug Administration (FDA) and a CE Mark Certification in the European Union.
"The Panta(R) XL Arthrodesis nail is an excellent addition to our family of hindfoot products, and expands our hindfoot portfolio to include a nailing system specifically targeted for the treatment of Charcot foot," said Robert Paltridge, President of Integra Extremity Reconstruction.
Charcot foot is a complication of diabetes that may occur in patients with neuropathy (nerve damage). When neuropathy is present, the bones in the foot become weakened and can fracture easily, even in the absence of major trauma. Reduced pain associated with neuropathy may contribute to continued ambulation, leading to destruction of the hindfoot joints. Surgeons may perform a TTC fusion to correct Charcot foot. TTC fusion differs from traditional ankle fusion because cartilage removal and bony fusion is performed in both the tibio-talar (ankle) joint and the adjacent joint between the talus and calcaneus (subtalar joint). .
The Panta(R) XL Arthrodesis Nail is a complement to the current Panta(R) product line, incorporating longer lengths and a conical extremity shape designed to reduce stress at the proximal tip of the nail. Another highlight of the system is the benefit of nail autodynamization. The proximal edge of the slot maintains compression while allowing dynamization with post-operative weight bearing, providing continuous compression. These product benefits allow for improved treatment of Charcot patients.
Based on available procedural data, Integra estimates that over 15,000 ankle fusions are performed annually, with an estimated market value of over $50 million.
The Panta(R) XL Arthrodesis Nail will be sold by Integra's Extremity Reconstruction sales organization, which focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is a global medical device company dedicated to improving the quality of life for millions of patients every year. Our products are used primarily in orthopedics, neurosurgery and general surgery. Headquartered in Plainsboro, New Jersey, Integra 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 Integra 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 Item IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2008 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 Gianna Sabella, Director of Corporate Communications (609) 936-2389 gsabella@Integra-LS.com
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