The NAVIGATE study evaluating electromagnetic navigation bronchoscopy (ENB) procedures using the superDimension navigation system to aid in lung cancer diagnosis, staging, and treatment.
Recently published results of a large, multicenter trial could go a long way toward boosting adoption of electromagnetic navigation bronchoscopy (ENB) procedures using Medtronic's superDimension navigation system to aid in lung cancer diagnosis, staging, and treatment. The 12-month results of the NAVIGATE study were published in the Journal of Thoracic Oncology.
"It's not enough anymore to just make a really amazing new technology, it has to be backed with clinical and economic evidence and one that allows really broad adoption around the globe to really impact as many patients as we can," Emily Elswick, vice president and general manager of lung health, which is part of the Minimally Invasive Therapies Group at Medtronic, told MD+DI.
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, more personalized treatment. NAVIGATE enrolled patients at 37 sites in the United States and Europe. The Journal of Thoracic Oncology publication includes 12-month follow up for 1,215 patients at 29 U.S. medical centers.
Covidien, now part of Medtronic, bought superDimension in 2012 for $300 million. It wasn't long after becoming part of Medtronic that the Dublin, Ireland-based company realized the need to prove the value of the technology, thus launching the NAVIGATE study. The study is considered the largest prospective multicenter trial evaluating ENB procedures using the superDimension system. NAVIGATE included a key finding that 65% of patients diagnosed with primary lung cancer were at early stages of the disease. And of course, early detection is critical to increasing the long-term survival rate.
Making sure that anyone with the right training and support can do the procedure was a major factor in doing the NAVIGATE study.
There have been close to 100 prior studies evaluating the superDimension system, but all of those studies involved a small number of patients and the procedures were performed by highly qualified physicians primarily at academic centers, according to Erik Folch, MD, chief of the Complex Chest Disease Center and co-director of International Pulmonology at Massachusetts General Hospital in Boston.
"So the criticism was, 'this doesn't apply to my patient, it doesn't apply to my setting," Folch, co-lead investigator of the NAVIGATE study, told MD+DI. "So we embarked on the first large prospective – looking forward, collecting all the information from the beginning – multicenter study in both the United States and Europe."
The NAVIGATE study included private practices, academic centers, and community hospitals, he said.
"We did not restrict physicians, we didn't tell them what to do we said 'just use the platform, tell us exactly what you did step by step, collect all the information and we will figure it out with these large numbers," Folch said. "We call this a pragmatic trial, instead of minimizing the generalization of the population and the people who can do it you just open it up and say 'let me see how things are being done in day-to-day practice."
The NAVIGATE study results showed the diagnostic yield of ENB (the proportion of patients who obtain an ENB-aided diagnosis) as supported by a one-year follow-up. The ENB procedure was successfully completed in 94% of study patients and an ENB-aided diagnosis was obtained in 73%. Compared to published diagnostic yields of 65% to 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.
A key finding in the NAVIGATE data was that 65% of patients diagnosed by physicians with primary lung cancer were in the early stages of the disease. With 49% of lesions less than 20 mm in diameter, NAVIGATE 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 the 19% to 25% percent rates typically seen with transthoracic needle biopsies.
"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 said.
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 recently launched a new prospective study evaluating this technology at two U.S. centers.
A third study, NAVABLATE, is designed to characterize the safety and performance of bronchoscopic thermal ablation using the Emprint ablation catheter kit with Thermosphere technology guided by the superDimension navigation system. The prospective, multi-center NAVABLATE study will be conducted in up to 30 patients globally.
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.