World-first device approved for humanitarian use

The FDA approved a 3D-printed talus implant (Patient Specific Talus Spacer) for “humanitarian use” in patients with avascular necrosis (AVN) of the ankle joint.

AVN, a rare and serious progressive condition in which a lack of blood to the area leads to the death of bone tissue, can be caused by a sudden injury or sustained tissue damage over time, and late-stage disease can potentially lead to partial or full collapse of the talus bone in the ankle. This implant — a joint-sparing alternative to surgical interventions such as fusing the foot and ankle joints or below-the-knee amputation — is “the first in the world and first-of-its-kind implant” designed to replace the talus in patients with AVN, a rare and serious progressive condition in which a lack of blood to the area leads to the death of bone tissue.

The agency reviewed data for the implant through the humanitarian device exemption process and labeled it a Humanitarian Use Device, or a device intended to treat or diagnose a disease or condition that impacts 8,000 or fewer individuals in the U.S. per year.

“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, MPH, 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.”

The talus implant is modeled using computed tomography imaging in order to fit a patient’s specific anatomy, the FDA explained. During replacement surgery, “the patient’s talus bone is removed and replaced with the implant, which is made from cobalt chromium alloy.”

This approval was based on data from a total of 31 patients and 32 talus replacement surgeries. “At three years post-operation, the average reported pain decreased from “moderate to severe” prior to surgery to “mild” post-surgery, and average range of motion in the ankle joint also improved,” the agency wrote. “These measures were assessed using standard subjective scoring systems for pain and functionality.” At three years post-surgery, additional surgeries were reported in three of the 32 cases — the most commonly reported adverse events were pain and scar tissue at the surgery site.

The Patient Specific Talus Spacer is manufactured by Additive Orthopaedics, LLC.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 725

Topic ID: 88,725,438,730,192,725,925,161