Partial results of a huge, real-world study of Medtronic’s (NYSE:MDT) superDimension LungGPS technology found that 65% of patients diagnosed with primary lung cancer (Stages I and II) were at early stages of the disease. Early detection of lung cancer is critical to improving patient outcomes long-term.
The results came from a 12-month follow-up of the 1,215-patient U.S. portion of the Navigate trial. Begun in 2015, the trial was designed to evaluate the performance of the LungGPS electromagnetic navigation bronchoscopy (ENB) technology that the superDimension device uses to navigate the lungs. Results from the European cohort will be released at a later date, the company said in a statement.
Published in The Journal of Thoracic Oncology, the study concluded that ENB-aided diagnosis can be obtained in approximately three-quarters of evaluable patients across a cohort. Navigate enrolled subjects at 37 sites in the U.S. and Europe. Twenty-nine of those sites were in the United States.
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, the company said. Medtronic (Fridley, Minn.) acquired the superDimension lung device as part of its 2015 purchase of Dublin, Ireland-based Covidien.
According to the American Cancer Society, lung cancer is the leading cause of cancer-related deaths in the United States. Most are diagnosed in the late stages (Stage III or IV), during which long-term survival rates drastically decline. When diagnosed at Stage I, the estimated 10-year survival rate climbs to 88%.
“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 co-lead study investigator Erik Folch, M.D., chief of the Complex Chest Disease Center and co-director of Interventional Pulmonology at Massachusetts General Hospital in Boston. “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.”
Medtronic said it recently launched a new prospective study at two U.S. centers to evaluate the latest generation of the superDimension, which uses advanced software to enhance the visibility of lung lesions in real-time and aid in improved diagnostic accuracy.this technology at two U.S centers. A third study, Navablate, will evaluate the safety and performance of Medtronic’s Emprint ablation catheter with the SuperDimension. This prospective, multi-center study will be conducted in up to 30 patients globally.
“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.
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, and is not available in the United States.