The purpose of the Q-sub proposal is to get FDA feedback on the pre-clinical and clinical data that would be acceptable for approval of the device. We will propose 1) the bench tests including fatigue tests of the device sufficient to determine safety and device long term durability, 2) the long-term pre-clinical animal model results used for initial data (current running at T3 labs) and if additional animal data is needed, and 3) we will propose that the six patients to be treated under A.3 and an additional two patients treated in 2018 and 2019 at Children’s Healthcare be included in the pivotal clinical data for device approval.
Based on clinical diagnosis from Drs. Maher, Goudy, Landry, Simon and Shashhidharan and a consultation with an outside physician (typically Dr. Wulkan, chief of pediatric surgery), a child will be proposed as a candidate for surgery. This diagnosis will be made by bronchoscopy and then quantified by studies that will include an inhalation and exhalation CT scan on which the ratio of airway segment (trachea, left mainstem bronchus and/or right mainstem bronchus) exhalation cross-sectional area to inhalation cross-sectional area will be less than 0.5.