Additive Orthopedics yesterday said it received FDA humanitarian device exemption for its Patient Specific Talus Spacer to treat avascular necrosis of the talus.
The Patient Specific Talus Spacer will be available as a humanitarian use device to treat avascular necrosis of the ankle joint, which is a serious condition that causes the death of bone tissue stemming from a lack of blood supply to the area.
“Avascular necrosis of the ankle, while a rare condition, is a serious and potentially debilitating one that causes pain and can lead to inhibited motion of the ankle joint, and in some cases, removal of part of the leg,” Raquel Peat, director of the FDA’s Center for Devices and Radiological Health’s Office of Orthopedic Devices, said in a news release. “Today’s action provides patients with a treatment option that could potentially reduce pain, retain range of motion of their joint and improve quality of life.”
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