Ion Research and Outcomes

Robust evidence characterizing the value that Ion shape-sensing robotic-assisted bronchoscopy is designed to deliver

14 mm

Median nodule diameter

91%

Diagnostic yield¹

91.5%

Sensitivity for malignancy

0%

Incidence of any pneumothorax

Research demonstrates the strong performance with the integration of Ion’s shape-sensing robotic bronchoscopy with mobile cone-beam CT

At Intuitive, our goal is to help care teams deliver answers to patients with suspicious pulmonary lesions by enabling high diagnostic yields and low complication rates.

In a multicenter study, data from 155 subjects with small (median 14mm) nodules biopsied using integrated Ion shape-sensing robotic-assisted bronchoscopy with Siemens Healthineers’ Cios Spin mobile cone-beam CT showed a diagnostic yield of 91%¹ with no (0) pneumothoraces.

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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.

Grant information

The Ion Registry

Intuitive has launched the US and European Ion registries to characterize the utilization of Ion in real-world practice. Aiming to enroll over 1,500 patients across both studies, capturing over 300 data points per patient, the Ion Registry will be the largest-ever dataset for navigational bronchoscopy.

Several abstracts have been presented at societal conferences providing preliminary insights. Examine the data on our conference abstract landing page.

See the abstracts

Clinical evidence

New clinical data is published frequently. Below, find some notable papers published about the Ion robotic-assisted bronchoscopy system.

1,121 Shape-sensing robotic-assisted bronchoscopic biopsies

Single center, retrospective review of a prospective institutional database including 940 patients and 1,121 nodules. This study evaluated the diagnostic yield, following patients up to 4 years post procedure, and surgical implications across a large, multi-physician cohort.

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Comparison of two robotic-assisted bronchoscopy platforms

A single center retrospective study assessing the diagnostic yield, complication rates, and procedural characteristics of shape-sensing robotic-assisted bronchoscopy compared to a electromagnetic navigation guided robotic-assisted bronchoscopy platform.

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Conebeam CT with shape-sensing robotic-assisted bronchoscopy vs with electromagnetic navigation bronchoscopy

A single center retrospective comparative study evaluating the performance of conebeam CT with two different navigation platforms for the biopsy of pulmonary nodules. Diagnostic yield was assessed according to two methods: (1) pathology findings from index procedure only and (2) including longitudinal follow-up (12 months) of patients with nonspecific benign findings.

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Procedural times with robotic-assisted bronchoscopy

A single center observational evaluation of shape-sensing robotic-assisted bronchoscopy procedure duration over time at a high volume site. Seven hundred procedures were performed between December 1, 2020 and October 16, 2023 and were included in this analysis. Additional outcomes include diagnostic yield, and pneumothorax rates.

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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.

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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.

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Study defined diagnostic yield allowed follow-up data when index bronchoscopy pathology results indicated tissue representative of nodule and consistent with a benign process. ATS/ACCP² diagnostic yield was 89%.
Gonzalez, A.V., et al., Assessment of Advanced Diagnostic Bronchoscopy Outcomes for Peripheral Lung Lesions: A Delphi Consensus Definition of Diagnostic Yield and Recommendations for Patient-centered Study Designs. An Official American Thoracic Society/American College of Chest Physicians Research Statement. Am J Respir Crit Care Med, 2024. 209(6): p. 634-646.

Disclosures and important safety information

Ion endoluminal system

As with any bronchoscopic procedure under general anesthesia, serious complications may include bleeding, pneumothorax (collapsed lung), cardiac-related complications, respiratory failure, air embolism, or death. For summary of the risks associated with bronchoscopy refer to www.intuitive.com/safety.

For risks, cautions, and warnings and full prescribing information, refer to the associated Ion System user manual(s) or visit https://manuals.intuitivesurgical.com/market.

Individuals’ outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, and/or physician/surgeon experience.