Robotic-Assisted Navigation System First Used for Lung Nodule Biopsies
Intuitive's new robotic-assisted fiber optic sensing navigation system has undergone its first human use for sampling small pulmonary nodules. The safety study reported no instances of pneumothorax or significant bleeding.
Intuitive, a medical device company, has reported the first human use of its robotic-assisted fiber optic sensing navigation system for sampling small pulmonary nodules. The system, designed for minimally invasive procedures, was evaluated in a single-center study involving 29 patients between 2016 and 2017.
The study primarily assessed the feasibility and safety of the navigation system in facilitating biopsies of pulmonary nodules measuring between 10 mm and 30 mm. Key safety endpoints included the rate of pneumothorax and excessive bleeding. The results indicated a 0% rate for both complications, demonstrating the system's safety profile in this early application.
The system's diagnostic yield, which measures the ability to obtain a conclusive sample, was reported at approximately 80%. The nodules targeted in the study were located in deeper generations of the lung airways, indicating the system's potential utility in accessing challenging peripheral lesions. Nodule sizes averaged around 12 mm.
While the evaluated system was an earlier iteration, its core technology and clinical workflow are similar to Intuitive's current Ion endoluminal system. The company notes that the Ion system is available in the U.S. and advises checking for regulatory status in other markets.