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-up will demonstrate the true-negative predictive value, and delineate the patient, lesion, and procedural characteristics contributing to diagnostic yield,” study authors wrote.
Medtronic began enrollment in the trial in March, looking to examine the safety and efficacy of the SuperDimension lung device it acquired along with Covidien early last year.
The 1st EU patient in the trial was enrolled at the Kepler University Clinic in Linz, Austria, the company said. Medtronic signed up the 1st U.S. patient at Pulmonary & Critical Care Associates of Baltimore last April.
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.
