A groundbreaking clinical trial has been initiated to evaluate the safety and effectiveness of 3D-printed bioresorbable devices designed to treat tracheobronchomalacia, a rare and life-threatening airway disorder in infants. This collaboration between Michigan Medicine and Materialise aims to secure FDA approval for these innovative devices, which could potentially save lives by supporting the airways of children suffering from the most severe forms of this condition. Currently, affected infants often depend on ventilators for survival. The trial will enroll 35 infants over an eight-year period across five children's hospitals in the United States.

The development of these biodegradable splints represents a significant advancement in pediatric care. For over a decade, University of Michigan Health teams have used these devices under emergency and compassionate use, but access has been limited. The new trial marks a critical step toward making this treatment more widely available, offering hope to families with few other options. The devices are customized to fit individual patients and are designed to degrade safely as the child grows.

Addressing a Critical Medical Need

Tracheobronchomalacia is a condition where the airway collapses, causing breathing difficulties that can be fatal in severe cases. Infants with this condition typically rely on ventilators to breathe. However, the new 3D-printed bioresorbable splints offer a promising alternative. These devices provide structural support to the airway, preventing collapse and allowing the infant to breathe normally. The trial, led by Michigan Medicine and Materialise, aims to validate the safety and efficacy of these splints, paving the way for broader use.

The journey to this point has been long and challenging. Over a decade ago, researchers at the University of Michigan developed the first biodegradable scaffolding specifically for this purpose. This innovation was born out of frustration with the lack of effective treatments for the most severe cases. The splint is attached externally to the trachea or mainstem bronchi, holding the airway open and enabling it to grow stronger over time. In 2012, the device was used for the first time to save a three-month-old infant, marking a milestone in pediatric medical technology. Since then, it has been employed in over 40 cases at Mott Children’s Hospital, demonstrating its potential to transform outcomes for these vulnerable patients.

Innovative Collaboration for Broader Impact

The clinical trial represents a significant leap forward in making this life-saving treatment accessible to more children. By enrolling 35 infants over eight years, the study will gather crucial data on the long-term effects and benefits of the 3D-printed bioresorbable splints. Participating hospitals include Mott Children’s Hospital and four other leading pediatric institutions across the U.S. The involvement of Materialise, a global leader in 3D printing, ensures that the devices are produced to the highest standards, leveraging decades of experience in medical applications.

Materialise’s Director of Clinical Engineering, Colleen Wivell, emphasized the transformative impact of 3D printing on personalized patient care. Surgeons increasingly integrate 3D-printed solutions into their practices, improving healthcare outcomes while reducing costs. The company’s Ann Arbor facility plays a pivotal role in producing these splints, contributing to the advancement of pediatric medicine. With the trial underway, there is renewed hope for families facing this devastating condition, as the path toward FDA approval and wider availability becomes clearer.