Novel Endovascular Robotic Surgical System Reaches Midpoint of Pivotal Clinical Trial
According to a press release from Microbot Medical Inc, the ACCESS-PVI pivotal trial has reached its midpoint, having enrolled and completed the follow up for 50% of patients. ACCESS-PVI investigates the LIBERTY® Endovascular Robotic Surgical System (LIBERTY®), developed by Microbot Medical Inc. Using a remote system, LIBERTY® seeks to improve utilization of surgical robots by eliminating the need for large and expensive capital equipment. This system could also reduce the radiation exposure and physical strain placed on the physician performing the procedure.
ACCESS-PVI is a prospective, multicenter, single-arm clinical trial evaluating the performance and safety of LIBERTY® among patients undergoing peripheral vascular interventions. Approval for initiation of the ACCESS-PVI clinical trial was based on successful completion of and positive results from the Good Laboratory Practice (GLP) pre-clinical trial. In the pre-clinical trial, over 96 robotic navigations were performed, wherein target vessels and surrounding tissue were examined and evaluated, following procedures done with commercially available intravascular catheterization devices manipulated via LIBERTY®. The first procedure in the ACCESS-PVI trial was performed in July 2024 at Brigham and Women’s Hospital, Boston, Massachusetts, by Dmitry Rabkin, MD, PhD.
The remainder of the enrollment and follow-up is planned to be completed by the end of 2024. This trial is part of the Investigational Device Exemption for LIBERTY® and data from it is expected to contribute to the submission of the premarket notification to the US Food and Drug Administration.
Sources:
Microbot Medical, Inc. Microbot Medical Announces the Successful Enrollment of 50% of the Patients in its Pivotal Human Clinical Trial for the LIBERTY Endovascular Robotic Surgical System. Accessed September 20, 2024. https://ir.microbotmedical.com/news-releases/news-release-details/microbot-medical-announces-successful-enrollment-50-patients-its
Microbot Medical, Inc. Microbot Medical Announced Positive Results of Its GLP Pivotal Pre-Clinical Study Where All Study Objectives Were Met. Accessed September 20, 2024. https://ir.microbotmedical.com/news-releases/news-release-details/microbot-medical-announced-positive-results-its-glp-pivotal-pre
Microbot Medical, Inc. Microbot Medical Enrolled the First Patient in its Pivotal Human Clinical Trial. Accessed September 20, 2024. https://ir.microbotmedical.com/news-releases/news-release-details/microbot-medical-enrolled-first-patient-its-pivotal-human
