Late Breaking Abstract - Safety and Performance of Total Lung Access to Peripheral Nodules in prospective, multi-center study

Background: Bronchoscopic access to peripheral pulmonary nodules(PPN) has always been a challenge due to anatomical and device constraint. Aims: This study is designed to evaluate the safety and performance of the Virtual Bronchoscopy Navigation (VBN) combined with Bronchoscopic Trans-Parenchymal Nodule Access (BTPNA) to obtain biopsy sample of suspicious SPN(s). Methods: A total of 106subjects were enrolled in the study comprising of 10hospitals located in U.S., EU and Asia between 8/2016 and 11/2018. Trained bronchoscopists planned the bronchoscopy procedures using Archimedes system (Broncus Medical San Jose, CA) using either VBN or BTPNA or combined methods to obtain biopsy samples. The planning process starts with import of high resolution CT scan, marking suspected PPN(s) and selecting suitable path to guide the bronchoscope to Point of Entry (POE) or biopsy location on airway wall for BTPNA or VBN approach, respectively. BTPNA approach utilized Archimedes kit to create and dilate the holes at POE followed by a guide sheath insertion directly toward the nodule under fused CT/fluoro guidance. VBN approach utilized common biopsy devices such as forceps and needle. Results: Summary of the data from the study is presented in the table below (Fig. 1). Conclusions: Analysis of the results demonstrated that combination of VBN and BTPNA provides safe and effective bronchoscopic access to PPN anywhere in the lungs.