3D-printed bioresorbable airway splints in clinical trials

Researchers at the University of Michigan and 3D printing company Materialise have launched a clinical study to evaluate the safety and efficacy of bioresorbable, 3D-printed airway splints. These custom-made implants are designed to help children with severe tracheobronchomalacia, a rare condition that causes airway collapse and can be life-threatening. The study marks an important step toward approval by the U.S. Food and Drug Administration (FDA).

“We have established a process that allows us to offer the customized airway splint as a last resort treatment for certain children with no other options but we need more research to make it available on a wider scale,” said trial principal investigator Richard Ohye, M.D., a pediatric heart surgeon at U-M Health C.S. Mott Children’s Hospital, who leads surgical implantation of the device.

Until now, these splints have only been used in individual cases under FDA emergency authorizations. For over a decade, University of Michigan physicians have utilized customized 3D-printed implants to stabilize the airways of affected children. However, this treatment has only been accessible to a limited number of patients. With the new clinical study, launched in January, 35 infants will be treated across multiple hospitals in the U.S. The goal is to gather long-term data on the safety and function of the bioresorbable implants.

The implant was developed by Glenn Green, an otolaryngology specialist, and biomedical engineer Scott Hollister. It is attached to the outer tracheal wall to keep the airway open. The structure is designed to grow with the child and biodegrade over time. The first implant was successfully placed in 2012 and documented in a publication in the New England Journal of Medicine. Since then, more than 40 children have been treated using this method. “We needed a revolutionary innovation to give these babies a chance to survive,” Green said.

Materialise, a Belgian company with extensive experience in medical 3D printing, is manufacturing the implants for the study. The company produces thousands of patient-specific implants and surgical instruments each year.

“The advent of technologies such as 3D printing and advanced visualization techniques has transformed patient-specific care,” said Colleen Wivell, Director of Clinical Engineering at Materialise. “Surgeons increasingly adopt 3D printing as part of their surgical workflow to bring personalized care to patients, improving healthcare and reducing costs overall. We’re so pleased to support this life-saving treatment and look forward to continuing to impact these children and their families.”

The ongoing study represents a significant step toward the widespread availability of these personalized implants. Through additive manufacturing, the treatment of tracheobronchomalacia could be permanently transformed, offering a new therapeutic option for affected children.