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.”
Additive Orthopedics’s Patient Specific Talus Spacer is a 3D printed implant that can be used in talus replacement surgery. It is made for each patient individually, modeled from computer tomography imaging to fit a patient’s specific anatomy. During the procedure, a patient’s talus bone is removed and replaced with the 3D printed implant, which is made from cobalt chromium alloy.
“Avascular necrosis of the talus is extremely painful and debilitating for these patients. 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,” president Greg Kowalczyk said in a news release. “This is a tremendous regulatory win which took significant effort from our team and I want to thank everyone, including the U.S. Food and Drug Administration, who assisted in making this technology commercially available in the domestic market for patients suffering from AVN.”
The company will immediately market and commercially launch the implant.