Microbot Medical has shared that it presented for the first time the data from its ACCESS-PVI pivotal trial at the Society of Interventional Radiology (SIR) annual scientific meeting (29 March–2 April, Nashville, USA).
The study was performed at three leading medical centres in the USA: Memorial Sloan Kettering Cancer Center (New York, USA), Baptist Hospital of Miami (Miami, USA) and Brigham and Women’s Hospital (Boston, USA). The late-breaking podium presentation was given by Francois Cornelis of Memorial Sloan Kettering Cancer Center.
The data concluded that robotic endovascular procedures using Microbot Medical’s Liberty endovascular robotic system are feasible and significantly minimise radiation exposure.
Highlights of the ACCESS-PVI study
- Successful robotic navigation was achieved in every case (n=20), yielding a success rate of 100%, meeting the primary endpoint of the study.
- No adverse device events (ADE=0%) were reported through the duration of follow-up.
- Mean difference in radiation exposure between operator and control was (-)29.8µS, resulting in a mean 92% relative reduction in radiation exposure.
- Median robotic navigation time to target was three minutes.
- Participating physicians reported Liberty performed as planned with a 100% satisfaction rate.
“The ACCESS-PVI data and the performance of the system throughout the study reflect the hard work that the team has put into Liberty over the past few years,” commented Harel Gadot, chairman, chief executive officer and president of Microbot Medical. “We are extremely pleased with the results in all aspects. As we shift focus to building our commercial capabilities and preparing for launch, we are confident that Liberty will be well received in the market.”
“We are very satisfied with the clinical data, as well as with the investigators’ feedback in terms of the short learning curve and intuitive operation of the device,” commented Juan Diaz-Cartelle, the company’s chief medical officer. “We are looking forward to working with interventional physicians and staff upon FDA’s [US Food and Drug Administration] clearance.”
Microbot Medical advises that Liberty is an investigational device pending FDA 510(k) clearance, and is currently not available for sale in the USA.
