STAR System Approved by FDA
Posted by
Jessica SmagaczMay 29, 2009 10:02 AMFDA recently approved a total ankle replacement system, the Scandinavian Total Ankle Replacement (STAR) system.
STAR may preserve some range of motion in arthritic or deformed ankles, according to the Atlanta Journal-Constitution.
This is the first type of system approved for ankle deformities or like injuries of the ankle. STAR uses bearings that move across a surface of flexible plastic (polyethylene).
When someone is experiencing or has arthritic or a deformed ankle, they may undergo a surgery called Fusion surgery. Fusion surgery is where the shin bone is cemented to the talus bone in the ankle. This surgery is suppose to stabilize the ankle but adversely decreases a patient’s ability to move their foot up and down.
The STAR system is an alternative and allows feet to move.
Director of the FDA’s Center for Devices and Radiological Health, Dr. Daniel G. Schultz said, “This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle. For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device.”
FDA executed a two-year study of 224 patients in order to approve the STAR system. The study found similar rates of adverse events, surgical interventions and major complications as fusion surgery.
Small Bone Innovations of Pennsylvania agreed to evaluate the safety and effectiveness of this medical device over the next eight years as a condition FDA offered in order to approve the STAR system.