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FDA Clears Small Bone Innovations’ Implant to Treat Thumb Arthritis



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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