Microbot’s ACCESS-PVI Pivotal Trial of Liberty Robotic System Accelerates Enrollment

October 8, 2024—Microbot Medical Inc. recently announced an acceleration of patient enrollment for the ACCESS-PVI human clinical trial of the Liberty endovascular robotic surgical system. With 80% of enrolled patients having completed the follow up period, the company anticipates completing the trial ahead of its previous expectation.

Microbot advised that it remains on track to file its 510(k) submission with the FDA by of the end of 2024.

According to the company, ACCESS-PVI is a prospective, multicenter, single-arm trial evaluating the performance and safety of the Liberty system in patients undergoing peripheral vascular interventions. The trial will support the 510(k) submission to the FDA and subsequent commercialization.

The company also announced that is has completed all biocompatibility tests, as required by its investigational device exemption (IDE) application and received full approval for the IDE study from the FDA.

In June 2024, Microbot announced that it had received approval from the FDA to commence its clinical trial, and in parallel complete biocompatibility testing. In parallel with the clinical trial, the company is performing additional customary bench testing, and these final results will be included in the company’s 510(k) submission to the FDA.