Medtronic's Minimally Invasive Therapies Group recently launched a 2,500-patient, international study to assess real-world impact of its superDimension navigation system.
The Company developed the study to support and validate the superDimension system, which the Company hopes will become the global standard-of-care for obtaining lung tissue biopsies from the periphery of the lungs.
The LungGPS technology used in the superDimension system is the first of its kind to enable Electromagnetic Navigation Bronchoscopy procedures (also known as ENB procedures).
ENB procedures provide a minimally invasive approach to access difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease and thereby lead to earlier, personalized treatment – potentially saving lives.
With a historical lack of effective, non-invasive diagnostic technologies, lung cancer remains the number one cancer killer in the world, accounting for more cancer deaths than breast, colon and prostate cancer combined.
Up to 75 centers around the globe will enroll patients in the single-arm, multi-center post-market observational study, known as NAVIGATE, to evaluate the diagnostic performance of ENB procedures.
The study will also determine how often physicians use the technology to successfully obtain biopsy samples from the surrounding lymph nodes and place fiducial markers or dyes to guide subsequent procedures to ablate or remove lung tumors.
The first enrolled patient underwent an ENB procedure at Pulmonary and Critical Care Associates of Baltimore, in Maryland on April 16, 2015. Patients will be followed for 24 months.
"With the introduction of ENB procedures, we can now navigate through the lung allowing us to screen for cancer and other diseases without surgery," said Erik Folch, MD, interventional pulmonologist at Beth Israel Deaconess Medical Center in Boston, and co-National Lead Investigator of the NAVIGATE study.
The ENB procedure allows patients to avoid surgery for benign disease and other invasive procedures like transthoracic needle aspiration.
According to the American Lung Association, lung cancer is the leading cause of cancer-related deaths in the US.
The superDimension system has received FDA 510(k) clearance in the US, CE Mark in Europe and it has also been approved for use in numerous international markets.