FDA Approves First In The World, First-of-Its-Kind Implant F
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The Patient Specific Talus Spacer is the first in the world to replace the talus, the bone in the ankle joint that connects the leg and the foot. The 3D-printed talus implant is for the treatment of avascular necrosis (AVN), a serious and progressive condition that causes the death of bone tissue.

AVN occurs when there is a lack of blood supply to bone tissue, causing it to become necrotic, meaning it dies. Late-stage AVN of the ankle may result in the talus bone partially or fully collapsing. Current available treatments include fusing the joints in the foot and ankle together or below-the-knee amputation.

The Patient Specific Talus Spacer is a 3D printed implant that can be used in talus replacement surgery. The spacer is made for each patient individually, modeled from computed tomography (CT) imaging. It is intended to be a joint-sparing procedure, as it allows the patient to retain motion in the ankle joint.

The FDA reviewed data from 31 patients and 32 talus replacement surgeries (one patient had operations on both ankles) with the implant for the Patient-Specific Talus Spacer through the humanitarian device exemption (HDE) process. At three years post-operation, the average reported pain decreased from moderate to severe prior to surgery to mild post-surgery.

By the three-year mark, out of 32 cases, there were three reported additional surgeries. The most common reported adverse events were pain and scar tissue at the surgery site. The FDA granted the HDE approval of the Patient Specific Talus Spacer to Additive Orthopaedics, LLC.

Source:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-world-first-its-kind-implant-treatment-rare-bone-disease-humanitarian-use-device
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