The U.S. Food and Drug Administration has cleared 3D-printed, patient-specific airway stents developed by Cleveland Clinic's Dr. Tom Gildea, section head of bronchoscopy, according to a news release.
Until now, the patient-specific stents, which are used to keep open the airways of patients with serious breathing disorders, were being implanted under the FDA's compassionate-use program. That program allows patients who have failed all available forms of treatment to receive investigational ones that are otherwise unavailable to the public, according to the release.
Gildea and his engineering team developed patient-specific stents that are designed using CT scans and 3D visualization software and then fabricated on a 3D printer and injected with medical-grade silicone. The process allows them to create stents that perfectly fit an individual patient's anatomy.
Standard airway stents are available in a limited number of sizes and shapes, but with patients' different anatomies, it can be difficult to get a perfect fit, especially for those who have complex conditions, according to the release. Ill-fitting standard stents can kink or bend or result in airway complications, including the growth of new tissue, mucus impaction and tissue death.
"Breathing is something many people take for granted, but for many of these patients, every breath can be a struggle," Gildea said. "It's been gratifying to see patients receiving the customized stents feeling relief right away."
The patient-specific silicone stents are potentially more tolerable than traditional silicone stents, which in certain patients may have to be frequently changed or cleaned due to a poor fit, according to the release. The Clinic pointed to studies in which the patient-specific stents lasted, on average, about a year, versus 90 days for stock stents.
An engineering team inside an orthopedic-focused Cleveland Clinic subsidiary developed the patient-specific stent and got it through FDA clearance. A new subsidiary, called VisionAir Solutions, will form around the technology, aiming to bring more personalized medical devices to interventional pulmonologists and patients.
This new spinoff company plans to begin providing personalized stents to patients by the end of the first quarter of this year in a controlled launch "at many of the country's top medical institutions," according to the release. Gildea and the Clinic may benefit financially if the technology is successful, according to the release.