Intuitive Ion Endoluminal System

Intuitive Ion endoluminal system – A robotic-assisted endoluminal platform for minimally invasive peripheral lung biopsy

The Intuitive Ion endoluminal system received clearance from the Food and Drug Administration (FDA) in February 2019.

The Ion endoluminal system is a robotic-assisted platform for minimally invasive biopsies of peripheral lung lesions, manufactured by Intuitive Surgical Inc. This American corporation is based in Sunnyvale, California, which mainly designs, develops and markets robotic-assisted products aimed to enhance outcomes of minimally invasive surgery procedures. The Ion endoluminal system includes the PlanPoint software platform, which generates 3-D images of the patient’s airway from a conventional CT scan of the chest, identifying boundaries and location of critical structures. The user can pre-plan a path for the nodule biopsy and export it to a USB flash drive.

During the bronchoscopy procedure the clinician uses the Ion’s controller to navigate along the pre-planned path. The bronchoscope catheter is 3.5 mm in diameter with a 2mm working channel. It articulates 180^o in any direction and can reach any lung segment. The system provides real time vision of the airway throughout navigation and calculates the shape of the catheter hundreds of times per second. Once the lesion is reached, the bronchoscopy catheter is locked in place and the biopsy needle is deployed into the target on a straight path. The system has a biopsy marker feature that allows a user to visualize multiple needle trajectories and track multiple biopsy attempts.

The platform has not been marketed for human use outside of the US. The manufacturer reports that the risks associated with the procedure are similar to those associated with conventional bronchoscopy performed through an endotracheal tube under general anesthesia. Although overall risk is low, serious complications can occur.