An analysis of 12-month results from NAVIGATE, the largest, prospective, multicenter trial designed to evaluate outcomes following electromagnetic navigation bronchoscopy? (ENB?) procedures using Medtronic’s superDimension? navigation system, shows positive results. [1]

Electromagnetic navigation bronchoscopy? is a minimally invasive technology that guides endoscopic tools to pulmonary lesions.? The technology has been evaluated primarily in small, single-center studies.

NAVIGATE enrolled subjects at 37 sites in the United States and Europe.

The study results, published in the Journal of Thoracic Oncology, included data for 1,215 patients at 29 medical centers in the United States.

Leading cause of cancer related death
According to the American Cancer Society, lung cancer is the leading cause of cancer-related deaths in the United States. [2]

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Today, the majority of lung cancer patients are diagnosed in the late stages (Stage III or IV), during which long-term survival rates drastically decline.[2] When diagnosed at Stage I, the estimated 10-year survival rate climbs to 88%.[3]

Early detection and immediate treatment dramatically increases the typical long-term survival rate.[2]

“These data demonstrate that, for the first time, both academic and community-based care clinicians can safely obtain a diagnosis in small, peripheral lung lesions, and then stage and prepare for future treatment in a single minimally invasive procedure,” said Erik Folch, MD, MSc., chief of the Complex Chest Disease Center and co-director of Interventional Pulmonology at Massachusetts General Hospital in Boston, and co-lead investigator of the NAVIGATE study.

“NAVIGATE is the first large, multicenter study to evaluate ENB diagnostic yield and complication rates with prospective, long-term follow up of negative cases. Because we looked at all cases-not just those with easily accessible lesions-NAVIGATE replicates real-world conditions and demonstrates that ENB has the potential to significantly accelerate lung cancer detection, and consequently improve the likelihood of a successful intervention,” Folch added.

Minimally invasive
Advancing the Lung Cancer Care Continuum Through Real-World Diagnostic Data
ENB procedures provide a minimally invasive, GPS-like approach to access difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease and potentially lead to earlier, personalized treatment. Earlier treatment has been associated with improved survival.[2]

The NAVIGATE study results showed the diagnostic yield of ENB (the proportion of patients who obtain an ENB-aided diagnosis) as supported by one-year follow-up. The ENB procedure was successfully completed in 94% of study patients and an ENB-aided diagnosis was obtained in 73%.[4] Compared to published diagnostic yields of 65-73% in previous small, single-center, and retrospective studies across different devices, the one-year diagnostic yield in NAVIGATE is consistent and generalizable across diverse operators.[4][5]

Key finding
A key finding in the NAVIGATE data was that 65% of patients diagnosed by physicians with primary lung cancer were at early stages of the disease (Stage I-II). With 49% of lesions less than 20 mm in diameter, the NAVIGATE study confirms that ENB is suitable for evaluating small peripheral lesions.

The procedure had lower complication rates than previously published for transthoracic needle biopsies; specifically, pneumothorax (collapsed lung caused by injury to the lung wall) occurred in only 4.3% of NAVIGATE patients, which is lower than 19-25% rates typically seen with transthoracic needle biopsies.[7]

Building on the NAVIGATE results, Medtronic continues to advance lung cancer diagnostics.

The latest generation of ENB, the superDimension? Navigation System Version 7.2 with Fluoroscopic Navigation Technology, uses advanced software to enhance the visibility of lung lesions in real-time and aid in improved diagnostic accuracy.

Medtronic has recently launched a new prospective study evaluating this technology at two United States centers.

Expanding the Care Continuum Through the New NAVABLATE Clinical Study
Medtronic is also committed to optimizing minimally invasive treatment solutions that accelerate recovery.

A third study, NAVABLATE, will characterize the safety and performance of bronchoscopic thermal ablation using the Emprint? ablation catheter kit with Thermosphere? technology guided by the superDimension navigation system.

NAVABLATE is a prospective, single-arm, multi-center, non-randomized study which is expected to enroll up to 30 patients in up to 3 sites and up to 3 countries.[8]

“We are dedicated to improving lung cancer care across the continuum with platform technologies that identify and manage patients, improve diagnostics, optimize treatment and accelerate recovery,” said Emily Elswick, vice president and general manager of Lung Health, which is part of the Minimally Invasive Therapies Group at Medtronic.

“We are setting the standard for clinical and economic evidence that substantiates the value of our innovative platforms for patients, providers and payers worldwide. Lung cancer remains the deadliest cancer and Medtronic is uniquely positioned to innovate, invent and disrupt with products and services that contribute to longer term survival,” Elswick added.

The superDimension system has FDA 510(k) clearance in the United States, CE Mark in Europe, and it has also been approved for use in numerous international markets including Japan, Korea, and China. The Emprint ablation catheter kit has CE Mark only, not available in the United States.

[1] NAVIGATE: Clinical Evaluation of superDimension? Navigation System for Electromagnetic Navigation Bronchoscopy? – NCT02410837
[2] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.
[3] Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS. Survival of patients with stage I lung cancer detected on CT screening. Henschke CI, et al. N Engl J Med. 2006;355:1763-1771.
[4] Folch EE, Pritchett MA, Nead MA, Bowling MR, Murgu SD, Krimsky WS, Murillo BA, LeMense GP, et al. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study.J Thorac Oncol. 2018 Nov 23. pii: S1556-0864(18)33456-7. doi: 10.1016/j.jtho.2018.11.013.
[5] Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ,Murgu SD, et al. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9.
[6] Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM.Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710.
[7] Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of CT-guided transthoracic lung biopsy: meta-analysis.Eur Radiol. 2017 Jan;27(1):138-148.
[8] Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint? Ablation Catheter (NAVABLATE) – NCT03569111

Last Editorial Review: January 31, 2019

Featured Image:?Young woman visiting radiologist for x-ray exam Courtesy: ? 2010 ? 2019 Fotolia. Used with permission. Photo 1.0: Medtronic system. Courtesy: ? 2010 ? 2019 Medtronic. Used with permission.

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