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 post-market 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 EU patient in the trial was enrolled at the Kepler University Clinic in Linz, Austria, the company said. Fridley, Minn.-based Medtronic signed up the 1st U.S. patient at Pulmonary & Critical Care Associates of Baltimore last April.
“The Navigate study represents our commitment to delivering meaningful solutions that support the early detection and treatment of lung cancer to save patient lives,” president Vafa Jamali said in prepared remarks. “The enrollment of patients in Europe for the Navigate study is a significant milestone and an important step to help establish ENB procedures as the gold standard for detecting lung cancer in the earlier, more curable stages.”
Covidien paid roughly $300 million, plus possible earnouts, to acquire SuperDimension in 2012. Medtronic closed the $50 billion deal for Covidien Jan. 26, 2015, nearly 18 months after 1st announcing its plans for the largest-ever medtech merger.