Ion Endoluminal System

Around the world, lung cancer is on the rise. Today, when a physician finds a small lesion on a patient’s lung, they have few options to perform a biopsy for tissue diagnosis. We recognized that innovation was needed to provide a minimally invasive solution with higher yield than previous approaches. The challenges are great: Early stage cancers are small in size and are most often located in the outer 1/3—far out of reach of traditional bronchoscopy tools. Also many lesions form outside the airway walls, where they cannot be seen by direct line of sight.

We invented a flexible robotic catheter that is small enough to reach the airways in all 18 segments of the lung, and precise and stable enough to navigate the tortuous path to get there. Our incredibly thin and flexible vision probe provides direct visualization the entire way. In many cases, the physician must be able to see beyond the walls of the lung to target the lesion. To solve this, we integrated an innovative fiber-optic shape sensor that provides precise location and shape information throughout the whole navigation and biopsy process.

So far the results have been exciting. An investigational study, “First Human Use of a New Robotic-Assisted Navigation System for Small Peripheral Pulmonary Nodules” promising early performance trends. The study was conducted with the Ion system and results were presented at the 2017 CHEST Annual Meeting. The results showed 97% feasibility and 0% pneumothorax or excessive bleeding. Early performance trends showed that for up to six months of follow-up there was 79.3% overall diagnostic yield and 88% diagnostic yield for malignancy. Compare this with traditional tools and techniques and the future looks exciting for what the Ion system can do.

Ion offers capabilities that are unique and powerful: Reach. We invented a flexible robotic catheter that is small enough to reach the airways in all 18 segments of the lung, and precise and stable enough to navigate the tortuous path to get there. Our incredibly thin and flexible vision probe provides direct visualization the entire way. Precision. In many cases, the physician must be able to see beyond the walls of the lung to target the lesion. To solve this, we integrated an innovative fiber-optic shape sensor that provides precise location and shape information throughout the whole navigation and biopsy process. Unlike other tracking technologies, our fiber optic shape sensor is not sensitive to metal objects. The information provided by our shape sensor is coupled with 3D planning software that helps physicians map a detailed plan of their patient’s lung. Targeting and biopsy are performed via these enhanced digital tools. Stability. Finally, we developed the Flexision needle—a flexible biopsy needle that slides through the twists, turns, and bends of the catheter smoothly without affecting aim. All of these technologies work together and strive to overcome the challenges of seeking a tissue diagnosis in the peripheral lung.