Researchers in Toulouse have developed custom-made silicone stents to open up blocked airways in patients with breathing problems, offering hope to people for whom conventional stents fail.

The prostheses are anatomically identical to the patients’ own tracheae or bronchi, and are an example of how personalised medicine is making inroads into the medical device arena, said Julien Mazières, an oncologist-pulmonologist working with a team at Toulouse University Hospital that developed the tailor-made implants in collaboration with the Toulouse-based start-up firm Anatomik Modeling.

"Every person could [ultimately] have their own stent, even if it is not a complicated case. It would be better than what is commercially available [at present]," said Mazières.

While standard stents are suitable for most patients with narrowing of their large airways, the devices fail in a significant minority of patients who have had lung transplants, tracheotomies or have tracheal diseases. Standard stents can move out of place, perforate tissue or cause inflammation that leads to further disease, said Nicolas Guibert, a pulmonologist on the team at Toulouse University Hospital.

He presented the results from a small clinical trial involving patients in whom all conventional treatments had failed at the EuroScience Open Forum 2018, currently underway in Toulouse. Nine patients were fitted with the new generation devices and followed up for a year. In all but one of the patients, the close fit between the personalised device and their own airways provided immediate improvement in their symptoms and quality of life, said Guibert. The ninth patient’s device did not fit properly.

The customised stents are created with computer aided design: CT-scan images are used to make a 3D virtual reconstruction of the patient’s unique airways, which is used to create a mould. A tailor-made prosthesis is then manufactured. The process, which has been patented, currently takes between three and five weeks, said Guibert.

The researchers are currently seeking regulatory approval to conduct a larger clinical trial, called TATUM, which will include less complicated cases.