FDA Approves Ankle-Replacement System

xrayThe U.S. Food and Drug Administration has approved the Scandinavian Total Ankle Replacement (S.T.A.R.) System for patients with arthritic or deformed ankles. The S.T.A.R. Ankle, developed by Small Bone Innovations of Pennsylvania, relies on bearings that move across a surface of flexible plastic. The device was designed as an alternative to traditional fusion surgery, in which the shin bone is cemented to the talus bone in the ankle. Fusion surgery typically stabilizes the ankle, but reduces the foot’s range of motion. The S.T.A.R. device may allow for greater rotation and movement in the ankle. It is the first and only FDA-approved device of its kind.

A two-year study of more than 200 patients found that the S.T.A.R. ankle had the same incidence of adverse reactions, follow-up surgery, and complications as fusion surgery. As a condition of the approval, Small Bone Innovations will evaluate the safety and effectiveness of the device over the next eight years.

Related video: Anthony Viscogliosi, Chairman and CEO of Small Bone Innovations

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