Ankle Replacement Device Approved
THURSDAY May 28, 2009 -- The U.S. Food and Drug Administration has approved the Scandinavian Total Ankle Replacement (STAR) system for people whose ankle is deformed or crippled by arthritis, the agency said Thursday in a news release.
The prosthetic device relies on bearings that glide across a surface of flexible plastic. It may permit greater movement and rotation of the joint than traditional fusion surgery, which involves cementing the shin bone to the talus bone in the ankle, the FDA said.
After two years of clinical study involving 224 people, researchers found the new device had about the same number of adverse reactions, complications and need for follow-up surgery as the fusion procedure, the agency said.
As a condition of approval, Pennsylvania manufacturer Small Bones Innovations Inc. will be required to further evaluate the product's safety and effectiveness over eight years.
The FDA has more about this approval.
Posted: May 2009