Artelon STT Spacer Increases Treatment Options For Thumb Arthritis
Small Bone Innovations's Artelon STT Spacer for early to mid-stage osteo-arthritis 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 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 STT joint is usually affected at a later stage in the progression of the disease than is the more commonly diagnosed carpal-metacarpal (CMC-I) joint."
The addition of the Artelon STT Spacer expands SBi's coverage in the treatment algorithm and enables surgeons to offer a complementary range of spacers for every stage in the continuum of this debilitating disease.
Mr. Viscogliosi noted that widespread use of hand-held devices is increasingly a cause of repetitive stress conditions in the thumb leading to earlier onset of arthritis and prompting more surgical procedures such as the use of Artelon spacers.
"As with other Artelon spacers, of which more than 3,500 have been implanted since 2004, benefits may include restoring joint stability, faster recovery and post-operative elimination of pain," he added.
Prior to the introduction of the Artelon Spacer, more aggressive procedures were and continue to be used as an initial surgical option. These procedures often involve removal of the trapezoidium bone and replacing it with tissue harvested from the forearm (known as an LRTI procedure) or complete fusion of the joint.
SBi estimates that more than 40,000 of these procedures are performed on arthritic thumbs annually and that the number could rise to 55,000 by 2010.
Mr. Viscogliosi added: "What these figures do not reflect is that many more patients elect not to seek surgery of any type and may rely on a combination of medication and bracing, but with Artelon technology now being offered by several hundred hand surgeons, these patients now have access to a much less aggressive form of treatment."
Artelon Spacers now offer a new, less invasive, surgical option that spares healthy bone and tissue. The Artelon CMC Spacer Arthro, cleared for marketing by the FDA earlier this year, permits minimally invasive arthroscopic implantation in patients at the earliest surgical stages of the condition.
The Artelon STT Spacer introduction stems from SBi's world wide marketing and licensing agreements with Artimplant, AB, of Sweden. The Artelon STT Spacer and the recently introduced Artelon CMC Spacer Arthro, for minimally invasive surgery, are the latest in a line of six products either already in the market or under development. Two more spacer products are planned for future introduction in the US: the Artelon MTP and Artelon DRUJ have received European CE marks but are not yet cleared for sale in the US.