Medtronic launches real-world study for SuperDimension lung device

Medtronic (NYSE:MDT) said today that it launched a huge, real-world study of the SuperDimension lung device it acquired along with Covidien earlier this year. 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 be...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Respiratory Medtronic Pulmonary Source Type: news