The 2-year, 2,500-patient Navigate trial is designed to evaluate the performance of the LungGPS electromagnetic navigation bronchoscopy technology the SuperDimension device uses to navigate the lungs. The single-arm, multi-center post-market observational study also aims to measure how often doctors use the system to obtain biopsies from surrounding lymph nodes and place markers to guide future procedures, Medtronic said.
The 1st patient in the trial underwent an ENB procedure at Pulmonary & Critical Care Associates of Baltimore April 16, the Fridley, Minn.-based company said. Covidien paid roughly $300 million plus possible earnouts to acquire SuperDimension in 2012; Medtronic paid $50 billion for Covidien in January.
“Medtronic is committed to providing innovative diagnostic and therapeutic solutions for lung disease that have the potential to transform care and improve outcomes for patients worldwide,” minimally invasive therapies chief medical officer Dr. Michael Tarnoff said in prepared remarks. “We hope the Navigate study will help confirm the impact of ENB procedures that we have seen in over 50,000 cases performed at more than 600 hospitals commercially and as part of prior clinical trials. Given the results seen to date, we are confident that this approach has the potential to become a recommended global standard of care to aid in diagnosis of peripheral lung lesions.”
“With the introduction of ENB procedures, we can now navigate through the lung allowing us to screen for cancer and other diseases without surgery,” added co-national lead investigator Dr. Erik Folch of Boston’s Beth Israel Deaconess Medical Center. “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.”
“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,” noted co-national lead investigator Dr. Sandeep Khandhar of Falls Church, Va.-based Inova Health. “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.”