Medtronic device to detect lung cancer shows promise in study - Star Tribune

Lung cancer kills more people than any other kind of cancer, even though 10-year survival rates approach 90 percent when detected in the earliest stages.

On Wednesday, Medtronic, which operates in Minnesota, touted new study data for its SuperDimension bronchoscope navigation system. It shows the system successfully detected early signs of lung cancer in a good proportion of patients in an all-comers population that included community hospitals and academic medical centers.

Data from the NAVIGATE study, published in the Journal of Thoracic Oncology, showed that in U.S. patients who got SuperDimension imaging and biopsies and were diagnosed with cancer, 65 percent of those diagnoses were for Stage I or Stage II cancers.

“The ability to diagnose early and stage in a single procedure may improve survival and reduce treatment costs,” study authors wrote.

Staging in a single procedure means that a patient can be imaged, biopsied and diagnosed to a specific “stage” of lung cancer with one procedure instead of multiple procedures.

Lung cancer can be diagnosed from Stage 0 to Stage IV.

SuperDimension was a Minnesota-based company before it was acquired by Covidien, and later acquired by Medtronic. The SuperDimension system consists of several components that together give doctors a way to directly look at and then take samples of nodules deep in the lungs that are hard to access any other way.

The system includes in-room navigation that works like a local GPS system, and a hand-held tool used by the physician that reaches deep into the lungs.

Combining actual live images with computer-generated navigation guidance, the system allows a doctor to accurately thread a narrow tube called a catheter deep into the lungs, far beyond the reach of traditional scopes.

Once the catheter is in place, the physician can insert any number of tools for imaging and taking samples of the hard-to-reach nodule.

The NAVIGATE study’s 12-month U.S. outcomes found that navigation was successful in 94 percent of the 1,157 lung lesion biopsy cases. Of the 1,215 total U.S. enrollees, 2.9 percent experienced a collapsed lung condition called pneumothorax that required further medical care, which the study called a “low” rate for that complication.

A key goal of the ongoing study is to measure SuperDimension’s “diagnostic yield,” which is the likelihood that the system will produce the correct information needed to made a diagnosis.

After 12 months, the system had an overall diagnostic yield of 73 percent, including cases where navigation was not successful. The true diagnostic yield at two years may move higher or lower, depending on how many patients with negative diagnoses remain cancer-free at 24 months.

“NAVIGATE suggests that diagnostic yield in the 66 percent to 75 percent range is achievable in challenging lesions across academic and community [hospital] settings,” the study says. “Excluding unsuccessful navigation cases [from the analysis] would have resulted in a diagnostic yield of 77.7 percent.”

Medtronic, which sponsored the study and co-authored the journal article, said in an announcement that the findings are important in furthering early detection of lung cancer. While the majority of patients are initially diagnosed with Stage III or Stage IV cancers, the 10-year survival rate is 88 percent when diagnosed at Stage I.

“Because we looked at all cases — not just those with easily accessible lesions — NAVIGATE replicates real-world conditions and demonstrates that ENB [Electromagnetic Navigational Bronchoscopy] has the potential to significantly accelerate lung cancer detection, and consequently improve the likelihood of a successful intervention,” said co-lead investigator Dr. Erik Folch, who is co-director of interventional pulmonology at Massachusetts General Hospital in Boston.

All of the patients in the study were treated with version 6.0 or higher of the SuperDimension system. The latest version, 7.2, is currently being tested in a new prospective study at two U.S. sites.

Meanwhile, another study is underway to test the safety and performance of using an ablation catheter called the Emprint, guided via the SuperDimension navigation system, to perform a cancer-killing procedure called “bronchoscopic thermal ablation.” About 30 patients will be enrolled in the NAVABLATE study in the U.K. and Hong Kong.

 

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