Israel-based Bendit Technologies’ steerable microcatheter has gained clearance from the US Food and Drug Administration (FDA), providing US clinicians with a new option for particularly intricate vascular procedures.
The Bendit17 microcatheter can be navigated with or without a guidewire. It is underpinned by Bendit’s proprietary real-time 3D steering technology and is intended to give clinicians greater control during neurovascular and peripheral endovascular interventions, according to the company.
Claimed to become the smallest microcatheter available on the US market, Bendit17 is poised to undertake its first commercial clinical procedures in the US in January 2026. In parallel, the company said it is actively pursuing additional regulatory clearances in other global territories.
In a preclinical study of Bendit17’s use in an animal model, the results of which were published in the Journal of NeuroInterventional Surgery, researchers reported the successful navigation of the microcatheter to all aneurysms in the subject without a guidewire and successfully recanalised a nearly occluded carotid artery and navigated the Bendit through a braided stent. The research team highlighted that, in contrast, they were unable to navigate a comparator device with a guidewire with equivalent success.
Bendit’s CEO Oz Cabiri commented: "FDA clearance of the Bendit17 is a major milestone for our team and a meaningful advancement for clinicians seeking greater control and navigational precision in complex vascular procedures.
“We look forward to making this technology available to physicians in the US and supporting improved care for patients worldwide."
GlobalData’s Medical Intelligence Center indicates that as of April 2024, 16 neuro microcatheters were in various stages of development worldwide, with each expected to gain regulatory approval within the next decade. According to further GlobalData analysis, the neuro microcatheter space is growing at a compound annual growth rate (CAGR) of 5.4% and is forecast to reach a valuation of $792m by 2034, up from $466.7m in 2024.
