Trial Enrollment for LIBERTY Robotic Surgical System Reaches Midpoint

Microbot Medical Inc. has enrolled half the patients in its ACCESS-PVI pivotal human clinical trial, which is designed to evaluate the LIBERTY Endovascular Robotic Surgical System. The company expects to complete enrollment and follow up this quarter and file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of the year.

“We are excited by both the achievement of this milestone, and physician feedback. We remain on track to complete the trial and subsequent submission of the 510(k) to the FDA before year end,” Microbot Medical Chief Medical Officer Juan Diaz-Cartelle, M.D., said.
 
ACCESS-PVI is a prospective, multi-center, single-arm, clinical trial designed to evaluate LIBERtY’s performance and safety in patients undergoing peripheral vascular interventions. The trial is expected to support a future 510(k) FDA submission and, when approved, subsequent commercialization.
 
“I have performed several procedures using LIBERTY during the trial and I am continuing to enroll patients,” stated Dmitry Rabkin, M.D., Ph.D., assistant chief, Division of Angiography & Interventional Radiology at Brigham and Women’s Hospital in Boston. “I am pleased with the ease of use and quick set-up of the robot, requiring, in my experience, a very short learning curve.”

Microbot Medical Inc. is a clinical- stage medical device company that specializes in transformational micro-robotic technologies to help improve clinical outcomes for patients and increase accessibility through the body’s natural and artificial lumens. The Investigational LIBERTY Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The company is confident the LIBERTY Endovascular Robotic Surgical System’s remote operation can potentially be the first system to democratize endovascular interventional procedures.