US FDA nod patient-specific airway stents developed by Cleveland Clinic doctor

The US Food and Drug Administration has given its nod to patient-specific airway stents recently. The airway stents have been developed by a doctor at Cleveland Clinic and they are designed using CT scans and proprietary 3D visualization software. The molds for the stents are then printed using a 3D printer and injected with medical-grade silicone. This process allows them to perfectly fit a patient's anatomy.

The stents are used to keep open the airways of patients with serious breathing disorders, such as those caused by tumors, inflammation, trauma or other masses. Until now, the patient-specific devices were being implanted under the FDA's compassionate use program, which allows patients who have failed all available forms of treatment to receive investigational ones not yet available to the public.

"Breathing is something many people take for granted, but for many of these patients, every breath can be a struggle," said 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."

Standard airway stents come in a limited number of sizes and shapes and are generally designed for larger airways. However, no two patient anatomies are alike, making it difficult to get a perfect fit, especially for those with complex conditions. Even in parts of the airways that are easily accessible, ill-fitting standard stents can result in stent kinking and bending as well as airway complications such as the growth of new tissue, mucous impaction, and tissue death.

Earlier 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 modelledU 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. and the same will be provided to patients by the end of the first quarter of 2020.