The US Food and Drug Administration (FDA) (www.fda.gov/home) has cleared patient-specific airway stents developed by Cleveland Clinic doctor Tom Gildea, who is head of bronchoscopy.

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 FDA’s ‘compassionate use’ programme, which allows patients who have failed all available forms of treatment to receive investigational ones that are 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, so it is difficult to get a perfect fit, especially for those with complex conditions.

Even in parts of the airway that are easily accessible, ill-fitting standard stents can result in kinking and bending, as well as airway complications such as the 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 proprietary 3-D visualisation software.

The moulds for the stents are then printed using a 3-D printer and injected with medical-grade silicone, creating stents that perfectly fit the patient’s anatomy.

Dr Gildea 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 customised stents feeling relief right away.

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

"Studies have shown that patient-specific stents last — on average — about a year, compared with 90 days for stock stents.”

A new subsidiary named VisionAir Solutions (www.visionairsolutions.com) 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 personalised stents to patients in a controlled launch at many of the USA’s top medical institutions.

It is estimated that about 30,000 airway stents will be implanted in the USA in 2020.