The purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children. The airway splint is bioresorbable, meaning the child's body will absorb the splint over about five years.
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The proportion of subjects that survive to 6 months post-splinting
Timeframe: 6 months post splint implantation
The Proportion of splinted regions with equal or greater than (≥) 50% average patency at approximately 4 weeks visit (window ±2 weeks) after splint implantation
Timeframe: Approximately 4 weeks (±2 weeks) post splint implantation