New clinical trial tests 3D printed devices to treat tracheobronchomalacia in infants

New clinical trial tests 3D printed devices to treat tracheobronchomalacia in infants

A new clinical trial will allow researchers to study 3D printed bioabsorbable devices aimed at treating children with rare and life-threatening respiratory condition tracheobronchomalacia disease.

The study, initiated by Michigan Medicine and Materialize, marks a critical step toward full Food and Drug Administration (FDA) approval for the innovative devices to support the airways of infants with the most severe forms of the disease.

Tracheobronchomalacia causes the airway to collapse, making breathing difficult and in severe cases can be fatal. Currently, infants with this condition often rely on ventilators to survive.

For more than a decade, University of Michigan health care teams have received expanded approval from the FDA on a case-by-case basis to use a unique 3D-printed Bioresorbable Airway Splint to treat these children under emergency and co-printed conditions. However, the groundbreaking treatment is currently only available to a limited number of patients.

Now, researchers at Michigan Medicine and 3D Printing Manufacturing Company are paving the way for broader use of the device through a clinical trial to test its safety and effectiveness. The trial opened in January, with the first patients now enrolled.

We have a process in place that allows us to offer the custom airway splint as a last resort treatment for certain children without other options, but we need more research to make it available on a more comprehensive level. “

Richard Ohye, MD, study installation investigator, a pediatric cardiac surgeon at UM Health CS Mott Children's Hospital, who is leading the surgical implantation of the device

Research teams plan to enroll 35 infants in Mott's eight-year study, as well as four other children's hospitals across the country.

Tracheobronchomalacia, which occurs in the cartilage in the trachea or main bronchi, varies in severity. In most children, symptoms are mild and appear by age three, once the tracheal cartilage has had time to grow stronger.

Mott Otolaryngology surgeon Glenn Green, MD, said he was frustrated by the lack of options for other children with the most severe forms of the disease who have faced poor outcomes.

“We needed a revolutionary innovation to give these babies a chance to survive,” Green said.

More than a decade ago, he worked with former U-M biomedical engineering professor Scott Hollister, Ph.D.

The device, developed by the University of Michigan, is placed on the outside of the bronchi of the trachea, or main trunk, to keep the airway open and prevent collapse. It was the first 3D implant for children that grew with the patient and was ultimately safely absorbed into the body.

In 2012, the tracheal splint was used for the first time to save the life of a three-month-old with a bad case of tracheobronchomalacia, and the successful outcome was outlined in oneNew England Journal of MedicineReport. With support from the Michigan Institute for Clinical and Health Research (Michr), Green and colleagues were able to obtain emergency use authorization to use the bioabsorbable scaffold through collaboration with the FDA, the Institutional Review Board, and hospital administration. It has since been used on more than 40 children at Mott.

Michr, Michigan Medicine and Materialize worked together to obtain approval for the 3D printed bioresorbable devices in a clinical trial. The trial is the next step toward FDA approval to treat children with the life-threatening condition.

Throughout the trial, the devices will be printed by Materialize, a major 3D printing company in Belgium that has pioneered numerous medical 3D printing applications. With over three decades of experience developing medical solutions, Materialize operates manufacturing facilities for these bioabsorbable splints in Ann Arbor. The company produces 280,000 personalized 3D printed instruments and implants per year, including 160,000 for the US market.

“The emergence of technologies such as 3D printing and advanced visualization techniques has transformed patient-specific care,” said Colleen Wivell, director of clinical engineering at Materialize. "Surgeons are increasingly adopting 3D printing as part of their surgical workflow to bring personalized care to patients, improve healthcare delivery and reduce overall costs. We are thrilled to support this life-saving treatment and look forward to continuing to impact these children and their families."

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