First-Of-Its-Kind Bioresorbable Implant to Help Children with Rare Respiratory Disease

Tracheobronchomalacia is a rare, life-threatening condition in which the cartilage in the trachea or mainstem bronchi develops abnormally, causing the airway to collapse and making breathing difficult for children. The severity of the condition can vary and it can also be fatal in some cases. Infants with tracheobronchomalacia often rely on ventilators to survive. While most children with this condition experience mild symptoms that resolve by age three, once the tracheal cartilage strengthens, there has been a lack of treatment options for those with the most severe forms of the disease. A new clinical trial is now underway to explore the use of 3D-printed bioresorbable devices to treat children with tracheobronchomalacia.

The trial, launched by Michigan Medicine (Ann Arbor, MI, USA) and Materialise (Leuven, Belgium), represents a significant step toward full Food and Drug Administration (FDA) approval for these innovative devices designed to support the airways of infants with the most severe cases of the condition. The research began more than ten years ago, focusing on the development of a biodegradable scaffold that could be tailored to each patient, manufactured as a tracheal splint. The device is placed on the outer side of the trachea or mainstem bronchi to help keep the airway open and prevent collapse. It was the first 3D implant designed for children, intended to grow with the patient and be safely absorbed into the body over time. In 2012, the tracheal splint was used for the first time to save the life of a three-month-old with a severe case of tracheobronchomalacia, with the successful outcome published in the New England Journal of Medicine. Through collaboration with the FDA, Institutional Review Board, and hospital administration, the researchers were granted emergency approval to use the bioresorbable scaffolding. For over a decade, the researchers have been able to obtain expanded access approval from the FDA on a case-by-case basis to use a pioneering 3D-printed bioresorbable airway splint for these children under emergency or compassionate use circumstances. The device has been used in over 40 children at Mott but this groundbreaking treatment has only been available to a limited number of patients.

With FDA approval now in place for the 3D-printed bioresorbable devices to be tested in a clinical trial, this marks a crucial step toward achieving full FDA approval for treating children with this life-threatening condition. With the clinical trial now underway, researchers at Michigan Medicine and Materialise are working to enable broader access to the device by evaluating its safety and efficacy. The trial, which opened in January, is currently enrolling its first patients. The study aims to enroll 35 infants over the next eight years from U-M Health C.S. Mott Children’s Hospital and four other children’s hospitals across the United States, with the devices being produced by Materialise. Throughout the trial, the devices will be manufactured by Materialise, a leader in pioneering medical 3D printing applications.

“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 Mott, who leads surgical implantation of the device.

“The advent of technologies such as 3D printing and advanced visualization techniques has transformed patient-specific care,” added 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.”

Related Links:
Michigan Medicine
Materialise