Bioresorbable Airway Splint Pivotal Clinical Trial

Inclusion Criteria:

* Subject must have clinically significant tracheobronchomalacia and:

  1. be unable to wean off of mechanical ventilation, and/or
  2. be currently dependent on a tracheostomy tube, and/or
  3. meet current indications for a tracheostomy or another surgical intervention for TBM
* Subjects must have a life expectancy of at least 2 years, exclusive of TBM
* Subjects must have a parent or legal guardian capable of giving consent on behalf of the subject, and must be willing and able to complete the requirements of clinical trial follow-up
* Subject must have a physician willing to provide follow-up clinical data, including a bronchoscopy at 2 years
* Subjects must be greater than 1 week of age and less than 4 years of age. (Infant subjects born preterm, with low birth weight, or small for gestational age are eligible for trial enrollment if their comorbidities do not present a contraindication to surgical intervention for subjects TBM and airways are of a size that can appropriately be treated with the range of splint sizes offered in this clinical trial)

Patency-Based Pre-Operative Inclusion Criteria:

\- Subjects must have tracheobronchomalacia in the trachea, left main bronchus, or right main bronchus a minimum patency of less than 50% in one of these regions

* Screening: In order for a subject to be sent to a clinical trial site for evaluation for the clinical trial, a subject must have tracheobronchomalacia with evidence of less than 50% minimum patency based on a Computed Tomography Scan (CT), Magnetic resonance imaging (MRI), or bronchoscopic exam at referring institution confirmed by an imaging or operative note from the local physician.
* At Enrollment: The subject must have tracheobronchomalacia with minimum patency of less than 50% in the trachea and/or left mainstem bronchus and/or right mainstem bronchus, based on expiration/inspiration CT performed at a clinical trial site performed during visit 1

Intra-Operative Inclusion Criteria:

\- The surgeon can safely dissect out the malacic trachea or bronchus/bronchi in order to place the splint

Pre-Operative Exclusion Criteria:

* Subject has significant fixed anatomic tracheal stenosis
* Subject has untreated complete tracheal rings
* Subject has single-lung anatomy
* Subject has single-ventricle cardiac anatomy
* Subject has external compression due to active malignancy, active infection, or an undrained cyst
* Subject has a non-bioresorbable airway stent. Recent removal of any stent will require verification of integrity of the airway wall
* Subject has a contraindication to surgery other than airway compromise
* Subject has a known hypersensitivity to polycaprolactone or hydroxyapatite, and/or a previous unusual reaction to bioresorbable sutures
* Subject has a genetic defect of cartilage formation
* Subject has significant bronchomalacia distal to the mainstem as the predominant source of subject's airway obstruction
* Membranous posterior wall intrusion is the predominant form of collapse