Microbot Medical has received the FDA’s blessing for its miniature, remote-controlled robot for endovascular procedures, designed to offer clinicians the freedom to sit comfortably and operate outside the cath lab’s radiation field.
Years in development, the Liberty system includes a fully disposable, palm-sized driver for advancing catheters and guidewires during minimally invasive procedures. Connected to a videogame-like controller, it is designed to be near-universally compatible with the interventionalist’s preferred hardware.
Microbot estimated that its initial addressable market in the U.S. will include about 2.5 million peripheral endovascular procedures annually before it turns its attention to securing regulatory green lights overseas.
“Obtaining FDA 510(k) clearance for Liberty marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics,” President and CEO Harel Gadot said in a statement. “This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare.”
“With our commercial readiness strategy being developed and executed since Q2 this year, we believe we are well-positioned to accelerate market entry,” Gadot said.
This past April, while Liberty was undergoing agency review, the company announced pivotal study data showing a 100% satisfaction rate among users.
The single-arm trial included 20 patients and demonstrated successful robotic navigation in every case, without clinicians being forced to switch to manual manipulation of the catheters and guidewires. In addition, no serious complications were reported in the three days following the procedure.
The study also logged a 92% reduction in operator radiation exposure with a median navigation time of three minutes. The results were presented at the annual meeting of the Society of Interventional Radiology in Nashville, Tennessee.