FDA grants clearance to patient-specific airway stents

Patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea have been cleared by the Food and Drug Administration (FDA).

The stents are used to keep open the airways of patients with serious breathing disorders, such as those caused by tumours, inflammation, trauma or other masses. Until now, the patient-specific devices were being implanted under 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.

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 growth of new tissue, mucus impaction and tissue death.

The patient-specific stents developed by Dr. Gildea and his engineering team are designed using CT scans and 3D visualisation software. The moulds for the stents are then printed using a 3D printer and injected with medical-grade silicone.

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

Patient-specific silicone stents is 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. 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.

With personalised medical devices more common in orthopaedics, the patient-specific stent was developed and FDA cleared by an engineering team inside an orthopaedic-focused Cleveland Clinic subsidiary. A new subsidiary named VisionAir Solutions will be formed around the technology with the sole mission of bringing more personalised medical devices to interventional pulmonologists and the patients who need them. By the end of the first quarter of 2020, this new spin-off company plans to begin providing the personalised stents to patients in a controlled launch at many of the country’s top medical institutions.