Ion Research and Outcomes

Meaningful evidence for lung biopsy with Ion integrated with mobile cone‑beam CT

90%

Approximate diagnostic yield (ATS/ACCP definition)¹

0%

Incidence of any pneumothorax

14 mm

Median nodule diameter

26.5%

Nodules with bronchus sign present

Research shows strong outcomes with Ion integrated with mobile cone-beam CT

At Intuitive, our goal is to help pulmonary care teams reach answers for patients with lung nodules by achieving high diagnostic yields and low complication rates through bronchoscopy. Evidence that Ion is helping achieve that goal continues to be supported in high-quality research studies.

Preliminary data from 155 subjects with small nodules enrolled in a multicenter study (NCT05562895) evaluating the integration of the Ion robotic bronchoscopy system and Siemens Healthineers’ Cios Spin mobile cone-beam CT shows an approximate 90% diagnostic yield¹ with no (0) pneumothoraces.

See the study abstract presented at the 2024 American Association for Bronchology and Interventional Pulmonology (AABIP) conference. The statistics above show preliminary study results.

See the study abstract

Research grants

The Intuitive Foundation offers research grants to support clinical and technology developments and further research in the field of robotic and pulmonary nodule management. Visit the Bronchoscopy Research Grant page for examples of research topics, application requirements, and submission deadlines.

Learn more

Outcomes research

Health Economics Outcomes Research (HEOR) is an integral part of Intuitive’s research support. Examining outcomes data helps generate evidence showing the potential role of Ion endoluminal systems in the patient journey for lung nodule biopsy.

Several recently published papers describe the current landscape of lung nodule biopsies and diagnosis. Examine the data in our publication summaries and access the full studies.

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Clinical evidence

New clinical data is published frequently. Below, find some of the recent papers published about the Ion robotic bronchoscopy system.

Robotic navigational bronchoscopy in a thoracic surgery

Single center, prospective institutional registry (real-world evidence) including 407 patients and 503 nodules, with a median size of 21 mm and 24.4% having a bronchus sign present. This study evaluated the diagnostic yield and clinical outcomes across a large, multisurgeon cohort using radial probe endobronchial ultrasound (R-EBUS) and two-dimensional fluoroscopy.

See the study

Robotic-assisted bronchoscopy vs. CT-guided biopsy

A dual-center retrospective review of 225 consecutive patients who underwent a robotic-assisted bronchoscopy (RAB) with Ion and CT-guided transthoracic biopsy (CTTB) for biopsy of pulmonary nodules. Clinical outcomes and complications were compared between the RAB and CTTB.

See the study

Radiation dose of cone beam CT with shape-sensing robotic bronchoscopy

A single-center prospective study including 241 subjects who underwent Ion robotic-assisted bronchoscopy procedures with fixed cone beam CT (CBCT). This study describes the technical factors associated with the use of CBCT combined with Ion shape-sensing robotic-assisted bronchoscopy, as well as clinical outcomes.

See the study

The ATLAS Study: Comparing bronchoscopic navigation platforms

Comparison study of three software platforms that generate virtual airway maps and pathways to a target lesion. See segmentation capability differences between planning software for electromagnetic navigation platforms and with Ion’s PlanPoint planning software.

See the study

Biopsy of ground glass and subsolid nodules with shape-sensing robotic-assisted bronchoscopy

A single center retrospective evaluation of shape sensing robotic assisted bronchoscopy in the biopsy of ground glass and subsolid nodules with a solid component less than 6mm in 22 consecutive patients. This publication also reports on sensitivity for malignancy and safety data.

See the study

Shape sensing robotic assisted bronchoscopy with mobile cone-beam CT

A dual center retrospective study assessing the diagnostic yield and sensitivity for malignancy of shape sensing robotic assisted bronchoscopy complemented with mobile cone-beam CT compared to ssRAB with standard 2D fluoroscopy.

See the study

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Strict diagnostic yield was calculated at index biopsy using the sum of specific benign and malignant findings divided by all nodules.

Disclosures and important safety information

Ion endoluminal system

The Ion Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

Information provided by the Ion endoluminal system or its components should be considered guidance only and not replace clinical decisions made by a trained physician.

For summary of the risks associated with bronchoscopy refer to www.intuitive.com/safety.

The Flexision Biopsy Needle is used with the Ion Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion Endoluminal System.