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FDA Clears Small Bone Innovations’ Implant to Treat Thumb Arthritis
09-Jul-2007
BUSINESS WIRE
Miami Surgeon Helped Develop Less Invasive Procedure
Small Bone Innovations, Inc. (SBi), has announced that its Artelon® CMC
Spacer Arthro has been cleared by the Food and Drug Administration for
marketing in the U.S. This product is an extension of SBi’s line of
implants to treat a common complaint: osteo-arthritis (OA) in the base
of the thumb.
Miami-based hand surgeon Dr. Alejandro Badia has conducted over forty
surgeries using Artelon spacers and helped SBi create the Arthro
product for arthroscopic implantation (‘key-hole’ surgery). “The most
convincing argument for using the Artelon spacer to treat early to
mid-stage thumb arthritis may be rapid recovery and return to normal
activities,” said Dr. Badia. “This could have a profound economic
impact as experience with the technology suggests patients may quickly
return to near normal function.”
The Artelon® CMC Spacer Arthro was designed to allow minimally
invasive, arthroscopic implantation in the joint between the first
metacarpal and the trapezium (see graphic). By avoiding violation of
the joint capsule, the procedure may offer significant advantages to
surgeons and their patients such as joint stability, faster recovery
and less pain.
Anthony G. Viscogliosi, Chairman and CEO of SBi, said: “By working
closely with surgeons, we are producing more advanced implants for
keyhole-type surgery, such as the Artelon® CMC Spacer Arthro, that
allow faster and more comfortable restoration of patients’
quality-of-life.” According to Mr. Viscogliosi, Artelon spacers have
been implanted using more traditional surgery in more than 3,000
patients in the U.S. and Europe since the technology was introduced
commercially in 2005. Dr. Badia has become a leading proponent of the
technology developed originally in Sweden by Artimplant AB and marketed
under license by SBi in the U.S. and elsewhere.
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