U.S. Food and Drug Administration clears new implant for marketing
NEW YORK, Sept. 21 /PRNewswire/ -- Small Bone Innovations, Inc. (SBi), a single-source provider of products, technology and education for the small bone and joint sector of the orthopedic industry, announced that its Artelon(R) STT Spacer has been cleared by the FDA for marketing in the US.
This product extends SBi's line of surgically implanted, degradable spacers to four applications with two others planned for future introduction. SBi introduced and began marketing this unique technology in the US in 2005 with the Arteon(R) CMC-I spacer for early to mid-stage osteo-arthritis (OA) in the base of the thumb.
The Artelon STT Spacer is implanted in the scapho-trapezio-trapezoidial (STT) joint between the scaphoid and trapezial-trapezioid bones near the base of the thumb.
*Dr. James Nunley, Chairman of the Orthopedics Department, Duke University, NC, said: "I am delighted to see FDA clearance of the Artelon STT spacer and, if it proves to be as good as the CMC-I spacer, it will be a tremendous benefit for patients likely to be presenting with a more advanced stage of OA in the base of the thumb."
*Dr. Amit Gupta, Assistant Clinical Professor in the Department of Orthopedics at the University of Louisville, KY, added: "Artelon is a major advance in the treatment of small joint arthritis by providing an inert interpositioning material between joint surfaces that eventually degrades."
The Artelon STT Spacer is similar in size to the Artelon CMC Spacer LG, except that it has a 'single-wing' design (an L-shape vs. a T-shape), of woven, degradable Artelon fibers. The spacer is designed to preserve the STT joint and to help restore joint function while minimizing the need to sacrifice healthy bone and tissue.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "The base of the
thumb is one of the joints most commonly affected by osteoarthritis. The
|SOURCE Small Bone Innovations, Inc.|
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