ILLUMISITE™ Platform: 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:
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 Fiber-optic 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).
CrossCountry™ Transbronchial Access Tool: The CrossCountry™ transbronchial access tool is to be utilized through a flexible endoscope with an extended working channel by physicians who are trained in endoscopic techniques to puncture the tracheobronchial wall and facilitate access of additional endobronchial tools for patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Always refer to the instructions for use included with the product for complete indications, contraindications, warnings, and precautions.
Federal law (USA) restricts this device to sale by or on the order of a physician.
First of its kind — the ILLUMISITE™ platform
SEE OUR VISION IN ACTIONClarity is key in your OR. And we understand relying on static images in a dynamic environment can make nodule biopsies using lung navigation technology challenging. CT-to-body divergence (CTBD) — the discrepancy between the static preop CT scan and the dynamic breathing lung — can impact accuracy and biopsy location, regardless of navigation technology.1 We can help you find the confidence to know where you are in a procedure and keep you on target.
These include:
Static CT image in dynamic lung environment
Changes from anesthesia
Tissue distortion due to the presence of a bronchoscope or catheter
Our ILLUMISITE ™ platform provides the problem-solving innovation that you need to achieve better patient outcomes. Overcome CTBD with the ILLUMISITE ™ platform which allows you to:
Static CT image in dynamic lung environment
Changes from anesthesia
Tissue distortion due to the presence of a bronchoscope or catheter
Our passion for evolving lung cancer care — from innovative surgical products to minimally invasive techniques — is at the core of our Mission.
VIEW OUR MISSION VIDEOOnce in the correct location, continuous guidance allows you to consistently target alignment across multiple tool uses. And you don’t need to reinsert the locatable guide and allows for multidirectional sampling.
LEARN MOREMore than 50 percent of nodules don’t have a visible airway on CT4. Our CrossCountry™ transbronchial access tool allow access to lung lesions without a bronchus sign.5
SEE IT IN ACTIONSee what they’re saying about the ILLUMISITE™ platform
Discover more about our ILLUMISITE™ platform and the benefits it offers. And become a part of efforts to understand and improve lung health care.
RESOURCESOur monthly series on lung health offers a forum physicians can use to discuss important related topics led by world-renowned key opinion leaders. Join the conversation and watch our past events:
Accuracy is everything: recent clinical evidence in navigation
Biopsy with confidence: correcting for CT-to-body divergence
Optimizing lung cancer care: building a lung health program
Innovation for optimized procedures: visualization and biopsy techniques
Dye marking and fiducial placement: enhance your visualization experience
REFERENCES
† 25 percentage point increase using fluoroscopic navigation (79%, 53/67) versus standard navigation (54%, 55/101)
†† As of June 2020
1. Pritchett MA, Bhadra K, Calcutt M, Folch E. Virtual or reality: divergence between preprocedural computed tomography scans and lung anatomy during guided bronchoscopy. J Thorac Dis. 2020;12:1595–1611.
2. Aboudara M, Roller L, Rickman O, et al. Improved diagnostic yield for lung nodules with digital tomosynthesiscorrected navigational bronchoscopy: Initial experience with a novel adjunct. Respirology. 2019. doi:10.1111/ resp.13609.
3. Based on internal report #DLD00032 for the ILLUMISITE™ Platform effective May 23, 2019, and #DLD00027 for the ILLUMISITE™ Platform effective April 3, 2015.
4. Folch E, Khandhar S, et al. Electromagnetic navigation bronchoscopy for peripheral pulmonary lesions: one-year results of the prospective, multicenter NAVIGATE study. J Thorac Oncol. 2019; 14 (3 ): 445-458
5. Based on internal report #DGR00596 for the ILLUMISITE™ Platform effective March 18, 2019,
6. Based on internal report DGR00452 for ILLUMISITE™ Platform.
7. Bhadra K, Mattingley J, Pritchett M. Electromagnetic navigation bronchoscopy with advanced fluoroscopy based localization and intraprocedural local registration for the evaluation of peripheral pulmonary nodules. Paper presented at: CHEST Annual Meeting; Oct. 23, 2019; New Orleans, LA.
8. Based on internal report DGR00512 for the ILLUMISITE™ Platform.
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