Airway stents developed by Cleveland Clinic doctor cleared for use by FDA

CLEVELAND, Ohio — 3D printed breathing stents, made specifically for each patient and developed by a Cleveland Clinic doctor, have been cleared for use by the U.S. Food and Drug Administration.

The patient-specific airway stents, used to keep open the airways of patients with serious breathing disorders, were developed by Dr. Tom Gildea, section head of bronchoscopy at the Clinic. The health system announced the FDA clearance Wednesday in a statement.

The new devices could help people who have trouble breathing due to tumors, inflammation, trauma or other illnesses, the Clinic said. An estimated 30,000 airway stents will be implanted in the U.S. in 2020.

Until now, the devices were being implanted under FDA’s compassionate use program, which allows patients, for whom all available forms of treatment have failed, to receive investigational ones not yet available to the public.

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Written by Julie Washington.

Originally published January 8, 2020.

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