Belgian 3D printing software company Materialise is leading a new US Food and Drug Administration (FDA) clinical trial for a bioresorbable, 3D printed tracheobronchial splint.
Developed in collaboration with the University of Michigan (U-M)’s Michigan Medicine and U-M Health, the device treats children with collapsed trachea and bronchial tubes. This condition, known as tracheobronchomalacia, affects approximately 1 in 2,100 children in the U.S., according to a study published in JAMA Otolaryngology–Head & Neck Surgery.
Initiated in January 2025, the trial will enroll at least 35 infants and children over an eight-year-long study at U-M Health C.S. Mott Children’s Hospital and other sites across the US.
The 3D printed medical splint was initially developed by former U-M Professor of Biomedical Engineering Scott Hollister, Ph.D., and Mott Children’s Hospital Otolaryngologist and Clinical Professor Glenn Green, MD, C.S. Materialise’s Mimics software was used to design the device, which was 3D printed for the first time in 2012 to restore a baby’s breathing. Now the team is working to expand the reach and marketability of its potentially life-changing offering through wider FDA approval.
“In partnering with U-M on this life-saving clinical trial, children now have access to this ground-breaking device and procedure,” commented Colleen Wivell, Materialise’s Director of Clinical Engineering. “We’ve worked tirelessly with U-M to get this project off the ground. I’m so proud to say that we are helping address an unmet need using Materialise’s best-in-class innovations. It’s about saving lives, improving quality of life, and making ongoing care more reasonable and sustainable.”
3D printed bioresorbable splint in new FDA trial
U-M’s original 3D printed tracheobronchial splint was implanted into a 20-month-old child called Kaiba in February 2012 after obtaining emergency clearance from the FDA. The baby boy had a collapsed bronchus, which blocked air from flowing into his lungs.
Hollister and Green developed the personalized splint using a CT scan of Kaiba’s trachea/bronchus. Leveraging Materialise’s Mimics software, they converted the scan data into a precise 3D model tailored to his needs. The splint was 3D printed using selective laser sintering (SLS) in polycaprolactone, a biodegradable biopolymer gradually reabsorbed by the body.
Once surgically placed around Kaiba’s airway, the splint expanded his bronchus, supporting natural healing and regrowth. Just 21 days after the procedure, Kaiba no longer needed ventilator support, and went on to make a full recovery.
Following Kaiba’s procedure, FDA Expanded Access pathways for Compassionate and Emergency Use have allowed over 40 pediatric patients to benefit from the team’s 3D printed splints. Materialise and U-M collaborated to secure an Investigational Device Exemption (IDE) held by Dr. Richard Ohye, MD, a pediatric cardiovascular surgeon at U-M and lead investigator. This exemption reportedly paves the way for clinical trials and, if the device gains FDA approval for marketing, its eventual widespread use.
As with Kaiba’s device, all 3D printed implants can be customized for each patient. Materialise’s Mimics platform and 3-matic modules translate anatomical data from CT or MRI scans into 3D models. These are used for pre-surgical planning and 3D printing on-site at a dedicated Materialise facility near the U-M hospital in Ann Arbor, Michigan.
According to Colleen Wivell, Director of Clinical Engineering at Materialise, the company’s bioresorbable 3D printed devices offer “immense potential” for soft tissue applications. “Materialise is at the forefront of such innovation, and we look forward to scaling up and making our innovations count,” Wivell noted.
“This project demonstrates Materialise’s commitment to transforming healthcare,” added Bryan Crutchfield, Vice President and General Manager, North America at Materialise.“ Our corporate responsibility to 3D printing and planning as drivers for a more personalized approach means that clinicians can tailor treatment plans to each patient’s unique anatomy and thereby significantly impact patient care.”
3D printing medical implants
3D printed reabsorable implants are being increasingly used in surgical procedures worldwide. Earlier this year, German medical startup BellaSeno achieved positive results from Australian clinical trials of its 3D printed resorbable breast implants. The studies, which began in 2022, assessed the use of biodegradable polycaprolactone as an alternative to traditional silicone breast implants for augmentation revisions and excavatum correction.
The trials involved 19 breast augmentation patients and 7 individuals with congenital chest wall condition pectus excavatum. All participants completed their one-year follow-ups with no major complications or instances of scaffold removal. According to Mohit Chhaya, CEO of BellaSeno, this data confirms that the 3D printed implants “not only meet the desired safety criteria but also show an improvement of patients’ quality of life.”
Elsewhere, Danish medical device manufacturer Particle3D has secured a Chinese patent for a new bio-ink that enables the production of fully resorbable, porous 3D printed bone implants. This biomaterial consists of ceramic suspended in a fatty acid matrix, designed to create patient-specific grafts with bone-like porosity.
Particle3D claims its implants can shorten surgery times, reduce complications, and improve aesthetic outcomes. Their macroporous structure allows for infusion with growth factors, antibiotics, and chemotherapy drugs. Notably, the company has found a way to dose medication effectively, enhancing metabolization in the kidney.
Who won the 2024 3D Printing Industry Awards?
Subscribe to the 3D Printing Industry newsletter to keep up with the latest 3D printing news.
You can also follow us on LinkedIn, and subscribe to the 3D Printing Industry Youtube channel to access more exclusive content.
Featured image shows Dr. Richard G. Ohye, MD, demonstrating the bioresorbable, 3D printed tracheobronchial splint device educational model. Photo via University of Michigan.
