Medical Device Network

Microbot shifts pivotal trial up a gear with completion expected ahead of schedule

A 510(k) submission to the US FDA is expected by the end of this year.

Microbot said that it expects to complete a pivotal trial evaluating its LIBERTY robotic system ahead of time, owing to an increased rate of patient enrolment.

The US-based company reported that 80% of patients have completed the follow-up period from the trial.

The study is currently estimated to finish by the end of October 2024, according to a ClinicalTrials.gov entry, although Microbot says it is on course to complete it ahead of “prior expectation.”

The company added that it remains on track to submit a 510(k) application to the US Food and Drug Administration (FDA) by the end of 2024.

ACCESS-PVI is a prospective, multi-centre, single-arm trial evaluating the performance and safety of Microbot’s LIBERTY system in human subjects undergoing peripheral vascular interventions.

Endovascular surgery is a minimally invasive procedure that uses catheters to access blood vessels for the treatment of vascular diseases.

The company’s technology is a single-use endovascular surgical robot designed to remove the need for large and expensive capital equipment.

Data from ACCESS-PVI, which is being conducted under an investigational device exemption (IDE) granted by the FDA, will be used to support the marketing application.

Microbot also announced that it has successfully completed all biocompatibility tests, a key part of the IDE application.

The robotics firm is also developing remote capabilities for the Liberty system, allowing the surgical procedure to take place without the presence of the surgeon at the concerned site. The company has an ongoing partnership with Corewell Health – Michigan’s largest healthcare system – to develop a telerobotic functionality.

The robotic surgical systems market is projected to grow from $3.3bn in 2023 to $7.2bn in 2033, with a compound annual growth rate (CAGR) of 15.7%, according to GlobalData analysis. The growth of the robotic surgical systems market is attributed to a push for less-invasive procedures in a growing elderly population.

J&J MedTech is eyeing an entry into the clinical trial space with its robot called Ottava. The company said it plans to submit an investigational device exemption application to the FDA in the second half of 2024.