FDA Approves Implant for Replacement of Arthritic TMC Thumb Joints

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FDA Approvals

PyroHemiSphere: Implant for Replacement of Arthritic TMC Thumb Joints

http://www.medscape.com/viewarticle/491771?src=mp

On Sept. 17, the FDA approved a hemi-arthroplasty implant

(PyroHemiSphere, made by Ascension Orthopedics Inc.) to replace the base

of the metacarpal bone in the trapezialmetacarpal (TMC) joint of thumbs

debilitated by arthritis.

The implant is made of a strong, low-friction, biologically fixed and

inert material (PyroCarbon) and does not require fixation with cement or

other compounds. It is the first joint implant made of this material to

be granted FDA approval.

The approval was based on the results of clinical studies showing that

the implant was effective in relieving pain, improving or preserving

motion, and reducing dislocated or subluxated TMC joints in patients

suffering from osteoarthritis, rheumatoid arthritis, and arthritis due

to trauma.