Positive 1-month safety results for Medtronic ’ s Navigate bronchoscopy trial

Medtronic (NYSE:MDT) today released 1-month data from the Navigate trial of its superDimension LungGPS system, touting the device as safe and effective based on the preliminary results. A total of 1,289 patients have been enrolled in the trial to date, which spans 37 sites across Europe and North America. The trial looks to evaluate the performance of Fridley, Minn.-based Medtronic’s LungGPS electromagnetic navigation bronchoscopy technology the SuperDimension device uses to navigate the lungs. The initial data comes from 500 procedures, 497 of which were lung lesion biopsies, 91 for fiducial placement and 9 for dye marking. The study reported a 4.4% rate of pneumothorax, with a 2.2% of the pneumothorax cases grade 2 or higher. The rate of bronchopulmonary hemorrhage was reported at 2.4%, with grade 2 or higher at 1%. Grade 4 respiratory failures were at 0.4% A single death was associated with the procedure, according to the study. Navigation was successful in 90.8% of cases, with 565 lesions investigated in the 1-month period. Diagnosis rate for malignant lesions was 45.2%, with 43.3% diagnosed as nonmalignant and 11.5% as inconclusive. Study authors touted a low rate of adverse events, but said that more data would be required to get a more accurate picture of the device’s safety and efficacy. “In the first 500 subjects enrolled, preliminary 1-month data demonstrate low adverse event rates among a generalizable cohort. Continued enrollment and 24-month follow-...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Imaging Respiratory Medtronic Source Type: news