Diagnostic screening systems

ILLUMISITE™ fluoroscopic navigation platform

<p>The ILLUMISITE™ platform gives you the power to access nodules in the pulmonary tract.</p>

Indications, Safety, and WarningsThe 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.
WarningsThe ILLUMISITE™ platform may only be used by a qualified bronchoscopist.ContraindicationsFlexible bronchoscopy should be performed only when the relative benefits outweigh the risks. Absolute contraindications include, but are not limited to:

Absence of consent from the patient or his/her representative, unless a medical emergency exists and the patient is not competent to give consent

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

For large patients, inability to place all three patient sensors within the sensing volume

The danger of a serious complication from bronchoscopy is especially high in patients with the disorders listed below. These conditions 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 for fiberoptic bronchoscopy in adults include but are not limited to:

Recent myocardial infarction or unstable angina

Uremia and pulmonary hypertension (possibility of serious hemorrhage after biopsy)

Lung abscess (danger of flooding the airway with purulent material)

Respiratory failure requiring mechanical ventilation

Known or suspected pregnancy (because of radiation exposure)

Features

One fully integrated navigational platform for lung biopsy

See the real target

With its ability to correct for CT-to-body divergence, the ILLUMISITE™ platform is clinically proven to help you accurately navigate lung nodules. With its unique fluoroscopic navigation technology utilizing digital tomosynthesis, you’ll have greater confidence that you’re in the right spot before you biopsy.^#,¶,1,7,8

Lock on in real time

At every stage of the biopsy procedure, you’ll remain on target with continuous guidance. The precision of continuous guidance makes continued target alignment possible across multiple tool uses — without the need to reinsert the locatable guide. And it’s designed for multidirectional sampling for a more thorough biopsy.^¶,7

Tools that take aim at lung challenges

Discover our comprehensive range of biopsy tools. From pulmonary needles to cytology brushes, our diverse portfolio ensures you have access to the tools you need for tissue sampling.

Clinically proven outcomes for lung biopsy

The VERITAS study: the ILLUMISITE™ platform versus CT‑guided biopsy

The ILLUMISITE™ platform is the first and only clinically proven solution to have a higher diagnostic outcomes compared to CT-guided biopsy.^§,9

In the VERITAS randomized controlled trial, the ILLUMISITE™ platform showed 79.0% diagnostic accuracy through 12-months of clinical follow-up, compared to 73.6% with CT-guided biopsy.^§,9Additionally, the ILLUMISITE™ platform showed zero false negatives at 12-month diagnostic follow-up.^§,9

Most important, lung biopsy with the ILLUMISITE™ platform has 6x fewer patient complications than CT-guided biopsy.^§,9

Diagnostic accuracy through 12-months of clinical follow-up^§,9

79.3%	73.6%
ILLUMISITE™ platform	CT-guided biopsy

Overall patient complications^§,9

5.0%	29.2%
ILLUMISITE™ platform	CT-guided biopsy

Hear experts discuss results of the VERITAS study

With the ILLUMISITE™ platform, higher complication rates are no longer a necessary tradeoff for the procedural outcome your patients require.^§,9

The RELIANT study: the ILLUMISITE platform™ vs. the Ion™* platform

The RELIANT trial found that diagnostic yield outcomes with the ILLUMISITE™ platform rivals the Ion™* platform.^‡,6

Additionally, lung biopsy procedures with the ILLUMISITE™ platform are shorter in duration when compared to the Ion™* platform.^‡,6

Diagnostic Yield: Overall^‡,6

75.5%	77.8%
ILLUMISITE™ platform	the Ion™* platform

Median procedure time: as measured from the start of airway registration to the removal of the bronchoscope^‡,6

32
minutes

ILLUMISITE™ platform

37
minutes

The Ion^TM* platform

More about the ILLUMISITE™ platform

Lung biopsies are challenging — the ILLUMISITE™ platform is helping to solve for that. (05:10)

Hear what clinicians are saying about the ILLUMISITE™ platform. (06:34)

Resources

ILLUMISITE™ Technology Brochure (open in new window)

View a detailed overview of the ILLUMISITE™ fluoroscopic navigation technology and how it, combined with the CrossCountry™ transbronchial access tool, gives you the power to display position and access nodules — moving lung health technology forward.

PRODUCT PDF 6 MB

Lung Health VERITAS Study Frost & Sullivan White Paper

VERITAS Clinical Study Frost & Sullivan White Paper (open in new window)

The VERITAS Study Comparing Navigational Bronchoscopy Versus CT-guided Biopsy developed by Frost & Sullivan. Featuring commentary from Dr. Maldonado, Dr. Kurman and Dr. Benn.

CLINICAL EVIDENCE PDF 4 MB

Lung Health VERITAS Data Clinical Summary

VERITAS Study Clinical Summary (open in new window)

View a Veritas clinical summary for lung health.

CLINICAL EVIDENCE PDF 131 KB

Lung Health Bronchoscopy RELIANT Clinical Summary

RELIANT Study Clinical Summary (open in new window)

View a clinical summary for the RELIANT study with ILLUMISITE™ Platform versus the Ion platform.

CLINICAL EVIDENCE PDF 140 KB

† Based on evidence from a single-center study.

‡ Based on non-inferiority single-center RCT. Procedure duration was measured in minutes from the start of airway registration to the removal of the bronchoscope.

§ Based on a non-inferiority RCT; safer biopsy based on overall complication rate.

¶ Based on evidence from a single-center prospective study including a total of 82 consecutive patients.

# Based on evidence from a single-center retrospective study including a total of 72 consecutive patients.

TM* Third-party brands are trademarks of their respective owners.

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.
Folch, E. E., Pritchett, M. A., & Nead, M. A. (2018). Brief Title: Electromagnetic Navigation Bronchoscopy for Lung Lesions Title: Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year
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 Bronchology Interv Pulmonol. 2021;28(1):10-20. doi:10.1097/LBR.0000000000000687.
Medtronic financial and market analysis as of November 2021 of ENB and robotic lung navigation systems in market demonstrating Medtronic leading market share as defined by percentage of capital system sales.
Münch T. et al., Electromagnetic Navigation Bronchoscopy (ENB) versus Shape-Sensing Robotic-Assisted Bronchoscopy (SS-RAB) lung navigation platforms - a cost-minimization analysis. The Professional Society for Health Economics and Outcomes Research (ISPOR) annual meeting, Atlanta, GA 2024.
R. Paez, et. al. Robotic Versus Electromagnetic Navigational Bronchoscopy for Pulmonary Lesion Assessment. Results from the RELIANT Randomized Trial [abstract]. Am J Respir Crit Care Med 2025;211:A5018. https://doi.org/10.1164/ajrccm.2025.211.Abstracts.A5018

Avasarala SK, Roller L, Katsis J, 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.
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
Lentz R. et al. Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules. The New England Journal of Medicine. Published May 18, 2025. DOI: 10.1056/NEJMoa2414059

ILLUMISITE™ fluoroscopic navigation platform

Features