Lung disease technologist Broncus Medical, Inc., has announced positive results from a study of its Archimedes™ Virtual Bronchoscopy Navigation System.
Dedicated to the development of diagnostic and therapeutic technology for lung disease, Broncus Medical’s Archimedes System offers real-time virtual bronchoscopic navigation with embedded intraprocedure fused-fluoroscopic guidance. It provides clinicians with a three-dimensional view and access to nodules anywhere in the lung.
Presented at the American Thoracic Society (ATS) 2018 International Conference, the new prospective study encompassed 25 consecutive patients treated at Temple University, 18 of whom had emphysema. The study examined the efficacy and safety of the Archimedes System for SPN diagnosis and the impact of lobe location, lesion size and orientation proximity of the lesion to the feeding airway and pleura on diagnostic accuracy.
Distance of SPN from the closest airway was 14.91 + 17.3 mm, demonstrating that most lesions did not have an airway leading to them (negative bronchus sign). Thirty-one percent of lesions were found to be malignant, 54 percent of lesions were found to be benign and only 15 percent indeterminate on final pathological review. For lesions that had a bronchus positive sign, the diagnostic yield approached 100 percent.
Nodules were located in a variety of locations in the lungs. Size of the nodules accessed was 25.6 +10.6 mm in the largest axis (range 11-46 mm), and 13.15 + 5.3 mm, and 35.10 + 34cm3 for major, minor axis lengths, and volume of the lesion, respectively. Despite the small size of the SPNs, overall diagnosis sensitivity was 90 percent for both malignant and benign nodules.
Proximity of nodules accessed to the pleura was 11.03 ± 9.7 mm (range 3.02 to 32.44 mm), with 55 percent of lesions ≤ 1 cm from the pleura, yet there were no instances of pneumothorax or postoperative respiratory failure. Two minimal biopsy-related airway bleeds were easily managed.
Broncus Medical is currently enrolling at least 100 patients in a larger study of the Archimedes System, which is expected to be completed by the end of the year.
“Virtual Bronchoscopy Navigation with embedded intra-procedure fused-fluoroscopy guidance can provide a safe, accurate and effective aid to diagnose peripheral solitary pulmonary nodule (SPN) ≤2 cm, even in patients with advanced underlying lung disease and close proximity to the pleura,” said Gerard Criner, MD, FACP, FACCP, lead author of the study, and Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University.
“We are building an evidence base demonstrating the significant benefits of our proprietary Archimedes System to enable minimally invasive diagnosis and treatment of lung cancer in a single procedure,” said Broncus President Henky Wibowo. “This study shows our technology can find and access lesions anywhere in the lung with high accuracy and diagnostic yield, and minimal risk, even in patients with underlying lung disease. We look forward to validating these results in a larger patient set.”
Source: Broncus Medical, Inc.