Electromagnetic Navigation (i-Logic System) during Flexible Bronchoscopy to Aid Diagnosis of Peripheral Lung Lesions

Proprietary names: inReach; Electromagnetic navigational bronchoscopy (ENB) system; i-Logic System; superDimension/Bronchus System; superTrax Biopsy Tools

Generic procedure names: electromagnetic guided bronchoscopy; electromagnetic navigation diagnostic bronchoscopy; ENB-assisted biopsy

Electromagnetic navigational bronchoscopy (ENB) is a minimally invasive procedure that uses electromagnetic technology to localize and guide endoscopic tools or catheters within the tracheobronchial tree. ENB is intended to aid diagnosis of peripheral lung lesions (that may be benign or malignant), especially in patients who are not suitable candidates for surgical biopsy.1 ENB is intended to enable a clinician to biopsy peripheral lesions, stage lymph nodes, place high-dose brachytherapy catheters, or insert markers to guide external beam radiation or surgical resection.1 Peripheral lung lesions can be located in any of the more than 100,000 bronchioles that cannot be visualized or reached with conventional bronchoscopy.2,3

Published data indicate that about two-thirds of lung lesions cannot be reached by a bronchoscope, and these patients would typically need to undergo more invasive procedures to diagnose peripheral lesions.4 Furthermore, small lesions (i.e., <2 cm in diameter) often cannot be diagnosed using conventional bronchoscopy.5-8

The manufacturer asserts that the technology offers the following advantages over transthoracic needle aspiration or thoracotomy with biopsy for assessing lung lesions:7,9,10

The system includes...