An adolescent girl has now joined a special group of three baby boys and one baby girl who’ve received 3D-printed tracheal splints to treat a congenital breathing condition called tracheobronchomalasia (TBM). All five continue to thrive thanks to the surgical procedures that helped their collapsed airways function normally and saved their lives.
The first child is now nearly four years old and an active preschooler. And, as planned by researchers at the University of Michigan who used additive manufacturing (AM) to produce the splints in their laboratory, the boy’s own tissues have successfully taken over the job of the implant, which has been almost completely reabsorbed by his body.
The five lifesaving procedures took place under FDA Emergency Clearance; the surgeries were performed at C.S. Mott Children’s Hospital, Ann Arbor, MI, which is affiliated with the University’s medical school. Now the engineering and surgical team that designed, built and implanted the splints is applying for an Investigational Device Exemption (IDE) from the FDA to treat an additional 10 patients. And they are preparing for a larger clinical trial that will compare the splint’s performance against the traditional solution of keeping a child with TBM on a ventilator.Read more