The Ion endoluminal system is a new robotic platform for minimally invasive biopsy deep in the peripheral lung. The system features an ultra-thin, human-controlled robotic catheter that allows physicians to navigate into hard-to-reach airways with unprecedented stability and precision. Unique to Ion is its innovative shape-sensing technology that measures the full shape of the catheter hundreds of times per second, providing precise location and shape information throughout the entire navigation and biopsy process. Finally, biopsy is enabled by our innovative Flexision flexible needle—which bends with the catheter and is able to pass through tortuous airways.

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. While CT-guided biopsy (where a needle is inserted from outside the lung) can be effective for tissue resection /sampling/yield, it requires a level of invasiveness that can lead to life-threatening complications (such as pneumothorax or excessive bleeding). Minimally invasive approaches (where a needle is inserted from inside the lung) are less risky, but are also far more difficult to do and are therefore less successful. 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 can be located anywhere in the lung, but are most often located in the outer 1/3—far out of reach of traditional bronchoscopy tools. In many cases, these existing methods require tools that are either too large or too limited to position accurately in the peripheral lung where airways can branch out to sizes less than 2mm in diameter. Also many lesions form outside the airway walls, where they cannot be seen by direct line of sight. Even if a physician can get close, they often must rely on limited external imaging and sensor technology to estimate where the lesion is in relation to the catheter.

To address these challenges, 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.

Seamless Integration.

While it is true that the Ion system brings something entirely new to the bronchoscopy suite, we believe its success depends on how well the technology can fit into existing environments and workflows. We took this into account in the design.

Portability and small footprint were key objectives so the system could be nimble enough to be placed in a standard bronchoscopy suite setup without requiring special accommodations. Our technology is designed to easily enter the room when required and leave the room when it is not. We also made sure to preserve the ability for the clinicians to work where they wanted to work—ensuring physical access to each other and to the patient.

When it comes to biopsy, the moment of truth happens at the needle. This is where years of practice and developing a feel for how the needle moves through tissue comes into play. We designed the Flexision needle to reproduce the touch and feel of traditional practices so physicians can use these well-honed skills when performing biopsies with the Ion platform.

We worked tirelessly with technical teams to streamline interactions, to provide a product experience that balanced the new with the familiar. Physicians who have experienced the system often comment on how every aspect of the product feels so considered —it's true that every part (physical and digital) was thoughtfully crafted to provide clarity and help them succeed.

Early detection is a powerful tool for defeating cancer, and Ion has potential of helping doctors provide answers for their patients. We look forward to the future and what physicians can do for their patients with this technology.