Results from the first clinical study assessing the safety and performance of Intuitive Surgical's new flexible robotics platform were released this week at the CHEST annual meeting. The findings suggest that the surgical platform is both safe, and provides a practical approach for sampling lung tissue.
The study was carried out at Australia’s Royal Brisbane and Women’s Hospital where the platform was used on 30 different patients to evaluate both the safety and feasibility of the surgical system.
The new system is a catheter-based technology that was designed to access some of the more difficult-to-reach areas of the body through natural openings, like the mouth. In this specific study, doctors used the platform to access the lungs to capture tissue samples for early lung cancer diagnosis.
When engaging in the study, researchers targeted nodules within the lungs that were smaller than two centimeters in diameter — areas that are beyond the reach of a human surgeon. In 29 out of 30 cases, the pre-planned target area was not only reached, but a suitable sample was extracted for assessment. In every case the procedure was carried out without complication, and no device-related adverse events were reported.
The study also showed that the robotic-assisted platform provides a flexible biopsy needle that was designed to accommodate a tight bend radius to help doctors navigate small spaces and reach areas of the body that were previously not accessible. The study indicated that the flexible needle performed very well in angulated positions, and navigated to the target area without complication. In every case where the system was used, no instances of pneumothorax or excessive bleeding were observed.
Doctors who participated in the study reported that the robotic-assisted technology not only provided them the ability to reach areas in the peripheral lung that were previously unreachable, but that the new technology would now offer the opportunity to diagnose abnormalities at a stage in which most patients wouldn’t even be aware of any possible issues yet. The company said this kind of early-stage diagnosis could open the door for earlier treatments and better patient outcomes.
With surgical robotic technologies on the rise, competition in the market has begun to give way to a bevy of different technologies in the field of robotic-assisted surgery. However, Intuitive Surgical CEO Gary Guthart remains confident that the company’s experience gives them an edge over any emerging competitive technologies.
As the company moves forward with the platform, Intuitive Surgical maintains that the technology is still under development as it seeks 510(k) clearance from FDA and prepares for U.S. marketing. Intuitive Surgical plans to continue to carry out additional clinical studies to further evaluate the safety and effectiveness of the platform, as the company strives to make intricate surgeries safer, less invasive, and easier on patients and doctors across the board.