Additive Orthopaedics' Patient Specific Talus Spacer was approved by the FDA for use in the U.S. as a humanitarian use device, meaning it treats a condition affecting fewer than 8,000 patients per year.
The implant is the first of its kind to be approved for use in the country and is used to treat avascular necrosis of the talus, according to a Feb. 17 news release. It is a custom 3D-printed implant that allows patients to regain motion and reduces pain.
"Avascular necrosis of the talus is extremely painful and debilitating for these patients," said Greg Kowalczyk, president of Additive Orthopaedics. "Surgical treatment options are below-the-knee amputation or joint fusion, which results in loss of motion of the ankle and can have poor outcomes. The Patient Specific Talus Spacer is another example of how 3D-printed devices can improve the standard of care."