XACT Robotics has obtained a new FDA clearance for its hands-free, needle-based surgery system, allowing it to be used to help steer and insert powered probes for ablation procedures.
This includes image-guided operations to burn out or freeze clumps of tumor cells in organs such as the kidneys, liver or adrenal glands without the need for open surgery. The agency’s green light adds to the robot’s already broad clearance for performing CT-guided percutaneous procedures like biopsies and targeted drug delivery.
“Ablation procedures are challenging to many users in terms of the accuracy and time required to place the ablation probes,” Harel Gadot, XACT's founder and executive chairman, said in a statement. “The proven ability of our system to reach relatively small targets, regardless of target movement or obstacles, with unparalleled accuracy and one insertion to target will provide better patient outcomes with greater efficiencies."
The former Fierce 15 winner’s ACE system includes a compact device that is mounted above the patient and does not require its own specialized or dedicated operating room.
Starting with scans of the patient and physician guidance, the device steers the tip of the needle to the desired location within the organ while adjusting for the patient’s involuntary movements without having to fully remove and reinsert the instrument.
It can also be piloted remotely, allowing an interventional radiologist to perform the procedure from outside the operating room and avoid additional exposure to radiation.
Last August, the company announced that it completed enrollment in its first U.S. clinical study to evaluate the ACE system’s performance in CT-guided lung biopsies for gathering tissue suspected of harboring cancer—typically a challenge, with a very small target area when a tumor may be in its earliest stages and located deep within a moving, breathing organ.
Other small robots making their way to the operating rooms include Interventional Systems’ Micromate, a boxlike device cleared by the FDA last year that also allows surgeons to conduct image-guided percutaneous procedures remotely.
In catheter-based operations, Microbot Medical—a company also led by Gadot—is developing remote-controlled hardware that straps to the patient’s thigh to help thread guidewires through the arteries from a distance, with a handheld remote not unlike a video game controller.