The system also addresses the challenge of tissue moving during the procedure, where patients are often awake, as well as irregular breathing, which adds to the complexity of using instruments, he noted. This allows physicians to diagnose and treat patients earlier rather than sending the patient home for “watchful waiting,” which is anxiety-provoking for patients. Gadot said the system has shown in more than 320 cases – both commercially and pre-clinical – an accuracy of less than 1.7 mm average tip to target. The ACE robotic system’s unique use of advanced algorithms gives it non-linear steering capabilities which allows access to hard-to-reach anatomical targets. The company anticipates full FDA clearance sometime this year. The remote has been conditionally approved by the FDA for emergency use during the public health crisis. The robotic system also comes with an optional remote-enabled feature, the ACE XTEND, which allows an operator to perform the procedure from another room, protecting the user from radiation. The physician is responsible for all the clinical decisions – planning and approving the procedure and then monitoring it while the robot performs the insertion and non-linear steering, Gadot explained. Gadot noted that the system uses “off-the-shelf” instruments, including ablation probes and coaxial needles from companies such as Medtronic plc, Boston Scientific Corporation and Johnson & Johnson (Pty) Ltd. The robotic system is placed on the patient’s body after confirmation of the procedure’s trajectory – the robot does its own registration – and then inserts the various instruments with non-linear steering and maneuvers around obstacles toward a target – without the physician touching the instrument. Its software allows interventional radiologists to assess real-time patient CT images and plan the procedure, including selecting the target, entry and checkpoints, and monitoring instrument advancement. The ACE robot is a handheld device about the size of an iPad. The ACE robotic system aims to improve patient outcomes and reduce readmissions by avoiding having to reposition the patient and requiring multiple instrument insertions to reach a specific target, which Gadot said is a problem with these types of procedures. Gadot said the ACE robotic system addresses limitations of manual methods and other image-guided percutaneous intervention systems by improving “accuracy, consistency and efficiency” of these types of procedures, as the name ACE implies. It’s incredible to see such a big market where nothing has been developed to solve this problem over the last few years.” – Harel Gadot “It’s incredible to see such a big market where nothing has been developed to solve this problem over the last few years.” “There are many unmet needs in this market. “There are many unmet needs in this market,” he said. ![]() Gadot puts the total addressable market for the system at 20 million interventional percutaneous procedures performed worldwide, including ablation, biopsies, drug delivery, drainage and pain management – all procedures which are typically done manually. On 18 May, XACT announced it received an expanded FDA clearance for the ACE robotic system for ablation probe insertion and steering, which, according to XACT, has the potential to save health systems time with fast and accurate probe placement. The FDA-cleared indication is for computed tomography-guided percutaneous interventional procedures. ![]() Harel Gadot, XACT’s founder and executive chairman, told Medtech Insight that the company expects to sell six ACE Robotic Systems by the end of June, adding to the four systems sold since it was first cleared by the US Food and Drug Administration in 2019. After COVID-related setbacks, placements of XACT Robotics Ltd.'s ACE hands-free robotic-assisted device for use in percutaneous interventional procedures are gaining traction in the US.
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