FDA Approves the Patient Specific Talus Spacer 3D-printed Talus Implant for Humanitarian Use – 1st in the World

February 17, 2021

FDA has approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. The Patient Specific Talus Spacer is the first in the world and first-of-its-kind implant to replace the talus, the bone in the ankle joint that connects the leg and the foot, for the treatment of avascular necrosis (AVN) of the ankle joint, a serious and progressive condition that causes the death of bone tissue stemming from a lack of blood supply to the area.

The implant provides a joint-sparing alternative to other surgical interventions commonly used in late-stage AVN that may disable motion 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, Ph.D., M.P.H., USPHS, director of the FDA’s Center for Devices and Radiological Health’s Office of Orthopedic Devices. “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.”

AVN is often caused by a sudden injury—such as a broken bone or a dislocated joint—or sustained damage to the tissue that develops over time, and it occurs when there is a lack of blood supply to bone tissue, causing it to become necrotic, meaning it dies. When the bones of a joint are affected, such as in the case of the ankle, the cartilage that keeps the bones from rubbing together can deteriorate, causing arthritis and pain.

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—a procedure which helps to alleviate pain caused by AVN but eliminates motion in the joint—or below-the-knee amputation.

The Patient Specific Talus Spacer is a 3D printed implant that can be used in talus replacement surgery. The talus spacer is made for each patient individually, modeled from computed tomography (CT) imaging, and is fitted to a patient’s specific anatomy. During the replacement surgery, the patient’s talus bone is removed and replaced with the implant, which is made from cobalt chromium alloy.

While fusion may become necessary in the future should the condition worsen, talus replacement surgery with the Patient Specific Talus Spacer is intended to be a joint-sparing procedure, as it allows the patient to retain motion in the ankle joint.

The FDA reviewed data for the Patient Specific Talus Spacer through the humanitarian device exemption (HDE) process. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year.

Data supporting the safety and probable benefit of the Patient Specific Talus Spacer include results from 31 patients and 32 talus replacement surgeries (one patient had operations on both ankles) with the implant. 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. These measures were assessed using standard subjective scoring systems for pain and functionality.

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.

Additional Resources:

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version