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