Braintree, Massachusetts-based Microbot completed the study using a porcine model. It operated under the guidelines of FDA-required levels of planning, controlling, monitoring and reporting.
Microbot said earlier this month that the study used its Liberty endovascular surgical robotic system to perform 96 robotic navigations. It evaluated target vessels with surrounding tissue microscopically after they were subjected to procedures using a number of commercially available intravascular catheterization devices. Microbot hopes data can support FDA investigational device exemption (IDE), leading to human clinical studies.
Liberty offers capabilities in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians. Microbot believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures.
“Today’s announcement marks another important milestone for the Company, as we continue our transition from R&D and pre-clinical phase into the clinical, regulatory and pre-commercial phase,” said Harel Gadot, Microbot Medical CEO. “We expect to submit our IDE application to the FDA soon and commence our pivotal human clinical trial, completing our transition to a clinical-stage company.”
