Medtronic’s Minimally Invasive Therapies Group is recruiting patients to participate in an international study to assess real-world impact of its superDimension navigation system, which Medtronic hopes will become the global standard-of-care for obtaining lung tissue biopsies from the periphery of the lungs.
The LungGPS technology used in Medtronic’s 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, Medtronic says.
Up to 75 centers around the globe will enroll 2,500 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. “With this minimally invasive diagnostic approach now available, we are able to manage thousands of patients with suspicious lung nodules that show up on computerized tomography (CT) scans without resorting to surgery. This important study holds the key to determining the real-world impact of this minimally invasive approach that, I believe, could significantly reduce the mortality of lung cancer.”
The ENB procedure allows patients to avoid surgery for benign disease and other invasive procedures like transthoracic needle aspiration.
“As lung cancer screening initiatives increase and we find more suspicious lung nodules, it is especially critical to provide minimally invasive diagnostic options earlier so patients can receive treatment sooner and have better chances of long-term survival,” said Sandeep Khandhar, MD, a CVTSA thoracic, surgical director of thoracic oncology at Inova in Falls Church, Virginia and co-National Lead Investigator of the NAVIGATE study. “We are at a crucial time where diagnostic and surgical technologies have advanced to a level where I believe there could be a significant shift in patient outcomes and many patients can go on to lead long, active and healthy lives after a lung cancer diagnosis, which was almost unheard of even 10 years ago.”