Microbot Medical announced that data from its ACCESS-PVI trial, evaluating the LIBERTY® Endovascular Robotic System for peripheral vascular interventions, will be presented at the Society of Interventional Radiology (SIR) annual meeting. The company also reaffirmed its expectation of receiving a 510(k) clearance decision from the FDA during the second quarter of 2025. Company executives and clinical team members met with SIR attendees in conjunction with the data presentation.
This podium presentation marks the first public unveiling of data from the ACCESS-PVI trial, offering valuable insights into the performance and safety of LIBERTY® in a real-world clinical setting. This information is crucial for interventional radiologists and vascular surgeons considering adopting the technology. The reaffirmation of the expected FDA decision timeline provides investors and the market with increased confidence regarding the potential commercial launch of the device.
The ACCESS-PVI trial is a prospective, multicenter, single-arm study evaluating the LIBERTY® system. The anticipated FDA decision in Q2 2025 represents a significant milestone for Microbot Medical, as it paves the way for potential commercialization of the first single-use, fully disposable endovascular robotic system. This could significantly expand access to robotic-assisted procedures by reducing the cost and complexity associated with traditional reusable robotic platforms.
A positive FDA decision would be transformative for Microbot Medical, enabling the company to transition to a commercial stage and potentially disrupt the endovascular robotics market. The subsequent commercial launch of LIBERTY® could democratize access to robotic technology for peripheral vascular interventions, benefiting both patients and healthcare providers. This development bears watching, as it could represent a paradigm shift in the delivery of vascular care.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
