1. DiBardino, D. M., Yarmus, L. B., & Semaan, R. W. (2015). Transthoracic needle biopsy of the lung. Journal of thoracic disease, 7(Suppl 4), S304–S316.
2. Folch, E. E., Labarca, G., Ospina-Delgado, D., Kheir, F., Majid, A., Khandhar, S. J., & Fernandez-Bussy, S. (2020). Sensitivity and safety of electromagnetic navigation bronchoscopy for lung cancer diagnosis: systematic review and meta-analysis. Chest, 158(4), 1753-1769.
3. Pritchett MA, Bhadra K, Mattingley JS. Electromagnetic Navigation Bronchoscopy With Tomosynthesis-based Visualization and Positional Correction: Three-dimensional Accuracy as Confirmed by Cone-Beam Computed Tomography. J BronchologyIntervPulmonol. 2021;28(1):10-20. doi:10.1097/LBR.0000000000000687
4. Avasarala SK, Roller L, KatsisJ, et al. Sight Unseen: Diagnostic Yield and Safety Outcomes of a Novel Multimodality Navigation Bronchoscopy Platform with Real-time Target Acquisition. Respiration. Published online September 03, 2021. doi: 10.1159/000518009.
5. Dunn BK, Blaj M, Stahl J, Speicher J, Anciano C, Hudson S, Kragel EA, Bowling MR. Evaluation of electromagnetic navigational bronchoscopy using tomosynthesis-assisted visualization, intraprocedural positional correction and continuous guidance for evaluation of peripheral pulmonary nodules. J Bronchology Interv Pulmonol. 2022.
6. Based on internal report #DRE00331, EDGE EWC catheter tip deflection study for GenCut™ core biopsy system, CrossCountry™ transbronchial access tool, and Arcpoint™ pulmonary needle. January 2017.
7. Based on internal test report #ADO110, A chronic, GLP study to evaluate the usability and safety of the coring tool in a porcine model. September 2014. Data on file
The ILLUMISITE™ platform is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use. WARNING: The ILLUMISITE™ platform may only be used by a qualified bronchoscopist. CONTRAINDICATIONS: Flexible bronchoscopy should be performed only when the relative benefits outweigh the risks. Absolute contraindications include, but are not limited to: lack of adequate facilities and personnel to care for emergencies such as cardiopulmonary arrest, pneumothorax, or bleeding, inability to adequately oxygenate the patient during the procedure. Conditions that are usually considered absolute contraindications, unless risk-benefit assessment warrants the procedure: Coagulopathy or bleeding diathesis that cannot be corrected, severe obstructive airways disease, severe refractory hypoxemia, unstable hemodynamic status including dysrhythmias. Relative contraindications or conditions involving increased risk include but are not limited to: Recent myocardial infarction or unstable angina, uremia and pulmonary hypertension, and known or suspected pregnancy. Please refer to Instructions for Use for complete contraindication and risk information.
©2024 Medtronic. Medtronic, Medtronic logo, and Engineering the extraordinary are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 04/2024 US-RE-2400178