superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

A Post-market Feasibility Study Evaluating Location Accuracy Using the superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology in Subjects Undergoing Lung Lesion Biopsy

The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.

The primary objective of this post-market feasibility study is to confirm the location accuracy of the local registration feature of the superDimension™ Navigation System Version 7.2 in subjects undergoing lung lesion biopsy.

Inclusion Criteria:

1. Subject presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation
2. Lesion is intended to be biopsied by the participating investigator
3. Subject is willing and able to provide informed consent to participate in the study
4. Subject is a candidate for an elective ENB procedure
5. Subject is over the age of 18

Exclusion Criteria:

1. Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB
2. Lesions within 10 mm of the diaphragm
3. The subject is unable or unwilling to comply with study follow-up schedule
4. The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
5. Female subjects who are pregnant or nursing as determined by standard site practices