A bioresorbable 3D-printed splint developed at the University of Michigan has saved the lives of four infants since 2013, thanks to FDA approval for Expanded Access to an investigational medical device. The infants were suffering from tracheobronchomalacia (TBM), a life-threatening congenital airway disorder.
Materialise has entered into an exclusive licensing arrangement with the University of Michigan to take the splint through clinical trials, in order to ultimately offer the newly granted patent in the marketplace. This marks a critical step towards bringing this technology to all children suffering from this condition.
Dr. Glenn Green and Dr. Scott Hollister of the University of Michigan used Materialise’s Mimics Innovation Suite to model and construct these splints using CT scans of patient anatomy. About 1 in 2,200 babies are born with TBM, which causes the trachea to periodically collapse. The tracheal splint, developed to save the lives of these children, is made with a biopolymer called polycaprolactone, a biodegradable material that is gradually absorbed into the infant’s body tissue over time.
“Here at Materialise, we strongly believe in the transformative power of great collaborations, such as the one we have enjoyed these past two years with Dr. Green, Dr. Hollister, and all others who have contributed to this live-saving application of 3D printing,” stated Bryan Crutchfield, Managing Director of Materialise USA. “This collaboration is proof that when the right skill sets and technologies are combined, solutions can be found for problems once thought impossible.”