Orthofix's 'ISKD' system gets 510(k) clearance from FDA
New Technology to Correct Limb-Length Inequality May Alleviate Back Pain as well as Save Limbs That Previously Would Have Been Amputated
Orthofix recently announced that its patented "ISKD" (Intramedullary Skeletal Kinetic Distractor) system for use in limb-lengthening procedures has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Orthofix will be marketing the ISKD system through its worldwide distribution network in 80 countries.
The novel ISKD system, an internal limb-lengthening device that uses a magnetic sensor to monitor limb-lengthening progress on a daily basis, complements Orthofix's current limb-lengthening product line, which includes the Limb Reconstruction System (LRS), a market leader. Orthofix estimates the current market for this new device to be in the $50 million range. Once the simplicity and patient benefits become understood, this market could expand.
"Since the ISKD system, a telescoping tubular structure, is completely implanted inside the bone to be lengthened, only the patient and surgeon need know the bone is being lengthened," said Charles Federico, Group President and Chief Executive Officer of Orthofix. "Once implanted, the IKSD lengthens the patient's bone gradually and, after lengthening is completed, the system stabilizes the lengthened bone."
Limb-lengthening is a technique that relies on the body's own ability to heal itself through the process of distraction osteogenesis (the development and formation of bone), which is achieved by surgically applying a fixator -- either externally or internally -- to the affected bone. Orthofix, together with surgeons at the University of Verona (Italy), have been world leaders in the field of limb-lengthening for over 18 years. Indeed, one of the world's leading medical journals, The Lancet, has praised the Verona group for its "innovative work" in the area of leg-lengthening and for achieving "impressive results ... up to 20 percent increase in bone length can be obtained with few complications" (May 7, 1988). The ISKD system now advances these previous pioneering efforts by not only generating satisfactory results but also insuring increased comfort for patients.
"With this advanced technology, the process of limb-lengthening is now a much more simplified procedure to correct limb-length inequality, even of small amounts, which otherwise could very well lead to back pain problems later in life for patients. Equally important, many of these same limbs that may have been candidates for amputation in the past can now be salvaged and lengthened, and their function restored because of this new technology," said J. Dean Cole, MD, orthopedic surgeon and co-inventor of the ISKD system who is a leading authority on the management of patients with deformed or shortened limbs, and President of Orthodyne Inc., from whom Orthofix has exclusively licensed the ISKD system.
Orthofix International N.V., whose 2000 revenues were $131.8 million, is a leading provider of high-value, minimally invasive medical devices for the orthopedic and trauma markets. For more information about Orthofix, please visit www.orthofix.com.
Certain of the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including, without limitation, the acceptance of new products in the market and the impact of competitive products and other risks and uncertainties. These are detailed from time to time in the Company's periodic reports (including the Annual Report on Form 20-F for the year ended December 31, 1999, filed with the United States Securities and Exchange Commission (the "SEC") and the Company's quarterly press releases which are available to shareholders and furnished to the SEC on Form 6-K).
Source: Orthofix International
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