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3D printed patient-specific airway stents approved by FDA

3D printed patient-specific airway stents approved by FDA

Written by David

January 9, 2020

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The U.S. Food and Drug Administration (FDA) has issued approval for patient-specific airway stents made with 3D printing. The custom stents, which are used to help patients with breathing disorders, were developed by Dr. Tom Gildea, a physician at the Cleveland Clinic.

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The recently approved stents can now be widely implemented to help patients suffering from serious breathing disorders caused by trauma, tumors, inflammation, etc. The customizable stents, which are made using a combination of 3D printing and silicone injection molding, have been used in the past but in a limited capacity. That is, the patient-specific breathing devices were viable under the FDA’s compassionate use program, which enables patients to seek out investigational treatment solutions if all available treatments have failed.

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The stents developed by Dr. Gildea and his team are based on data from CT scans, which is transformed into a 3D printable mold using a proprietary 3D […]

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