FDAnews Device Daily Bulletin

ARTIMPLANT SPACER RECEIVES CE-MARK

March 20, 2006
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The Artelon DRU Spacer, for the treatment of osteoarthritis in the distal radioulnar joint in the wrist, has received the CE mark, the biomaterials company Artimplant has announced.

Since fractures in the wrist region often result in complications, including osteoarthritis in the joint surface between the distal radius and ulna which often leads to wrist pain, limitation of forearm rotation and the reduction of grip strength, the Spacer allows the forearm to function in a natural way, the company said. Made of Artelon, a long-term degradable biomaterial acts as a temporary support system to facilitate formation of new host tissue. It has mechanical properties similar to human tendons and biocompatibility in hard and soft tissue.