Thursday, February 18, 2021
Additive Orthopaedics, LLC., announced today it has received an approval order from the U.S. Food and Drug Administration ("FDA") for its Humanitarian Device Exemption ("HDE") application for the Patient Specific Talus Spacer for treatment of avascular necrosis of the talus. The approval order makes the Additive Orthopaedics Patient Specific Talus Spacer the first and only patient specific total talus replacement implant approved by the FDA for use in the United States.
The Patient Specific Talus Spacer is indicated for Avascular Necrosis ("AVN") of the ankle joint. Under the HDE, the Patient Specific Talus Spacer will be made available as a humanitarian use device, defined by the FDA as one intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.
The Patient Specific Talus Spacer is an additively manufactured, or 3D printed, patient specific implant that is designed and made individually for each patient using CT image data. The device allows a patient to regain motion and reduce pain until the time a fusion potentially becomes necessary.
Greg Kowalczyk, President of Additive Orthopaedics, stated, "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. 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 marketing and commercial launch of the Patient Specific Talus Spacer in the U.S. is expected to commence immediately.