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The 3D-printed implant is patient specific and modeled after the anatomy of the individual.
The US Food and Drug Administration (FDA) has approved the Patient Specific Talus Spacer, a first-of-its-kind and first in the world humanitarian use device for the treatment of avascular necrosis (AVN) of the ankle joint.
"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," said Capt. Raquel Peat, PhD, M.P.H., USPHS, director of the FDA's Center for Devices and Radiological Health's Office of Orthopedic Devices, in a statement.
"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,” she continued.
The implant is designed to provide a joint-sparing alternative to other surgical interventions used in late-stage AVN that may hinder motion of the ankle joint.
Modeled from computed tomography (CT) imaging, the Patient Specific Talus Spacer is a 3D printed implant that is created and fitted for the patient’s specific anatomy.
The approval was supported by data from 31 patients and 32 talus replacement surgeries using the implant.
The average self-reported pain pre-surgery was “moderate to severe.” However, the reported pain decreased to “mild” 3 years following operation.
Data also showed an improvement in the average range of motion in the ankle.
Furthermore, there were 3 reported additional surgeries by year 3. The most commonly reported adverse events associated with the implant were pain and scar tissue at the surgery site.
The approval was granted to Additive Orthopaedics, LLC, through the humanitarian device exemption (HDE) process.