FDA clears 3D-printed airway stents tailored to patient anatomy

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The Food and Drug Administration has approved patient-specific airway stents developed by a Cleveland Clinic physician that are designed using CT scans and proprietary 3D visualization software.

The lung stents, which are matched to the exact specifications of a patient’s natural anatomy, enable the opening of airways for individuals with serious breathing disorders.

“Breathing is something many people take for granted, but for many of these patients, every breath can be a struggle,” says Tom Gildea, MD, section head of bronchoscopy at the Cleveland Clinic, who invented the technology. “It’s been gratifying to see patients receiving the customized stents feeling relief right away.”

Previously, the only method for implanting these personalized stents in patients was under the FDA’s compassionate use program, which allows for the use of unapproved drugs or medical devices. In 2020, about 30,000 airway stents will be implanted in the U.S. and the hope is to make available more customized devices to interventional pulmonologists and their patients with serious breathing disorders.

“We are excited to be able to bring this technology to more patients across the country and grateful for the patients and donors who have worked with us to help pioneer this technology,” adds Gildea.

According to the Cleveland Clinic, the stents which are modeled from patient-specific dimensions, printed using a 3D printer and injected with medical-grade silicone have shown greater acceptance by the body, increased comfort and improved performance outcomes.

“They have the potential to be more tolerable than traditional silicone stents, which, in certain patients, may have to be frequently changed or cleaned due to problems from a poor fit,” contends the Cleveland Clinic. “In studies, the patient-specific stents lasted, on average, about a year versus 90 days for stock stents. Furthermore, the patient-specific stents exhibited shorter procedure times and improved patient-reported symptoms, leading to a reduced need for stent changes and modifications.”

The personalized stents will be manufactured by a new Cleveland Clinic spin-off company called VisionAir Solutions. A controlled launch to begin providing the stents to patients is slated to start by the end of the first quarter of 2020 at some of the nation’s leading medical institutions.

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