Bendit Technologies’ steerable microcatheter receives FDA clearance in the United States

ISRAEL— Bendit Technologies has received clearance from the U.S. Food and Drug Administration (FDA) for its steerable microcatheter, marking a major advancement for clinicians performing intricate vascular procedures.

The newly approved Bendit17 microcatheter gives medical professionals in the United States a sophisticated new tool for use in neurovascular and peripheral endovascular interventions, procedures that often demand exceptional precision and control.

The Bendit17 microcatheter can be guided either with or without a guidewire, making it highly versatile compared to conventional devices.

It incorporates Bendit’s proprietary real-time 3D steering technology, which enables clinicians to maneuver the device more intuitively through complex vascular pathways.

According to the company, this technology is designed to enhance navigational accuracy and optimize outcomes during complex interventional procedures.

With these advanced features, Bendit17 is expected to help improve patient safety and procedural efficiency, especially in cases involving delicate or hard-to-reach vessels.

Bendit Technologies stated that the Bendit17 is anticipated to be the smallest microcatheter available on the U.S. market once fully commercialized.

The company plans to begin its first clinical procedures using the device in the United States in January 2026.

At the same time, it is actively pursuing additional regulatory approvals in other global markets to expand its reach beyond the U.S. healthcare system.

In a preclinical animal study published in the Journal of NeuroInterventional Surgery, researchers successfully navigated the Bendit17 microcatheter to all targeted aneurysms without using a guidewire.

They also reported successful recanalization of a nearly occluded carotid artery and demonstrated the microcatheter’s ability to pass through a braided stent—a task in which a comparator device, even with a guidewire, failed to achieve equivalent success.

 These findings highlight the Bendit17’s flexible design and the potential for improved clinical outcomes in both neurovascular and peripheral interventions.

Commenting on the FDA clearance, Bendit Technologies’ CEO, Oz Cabiri, described the approval as a significant milestone for the company and a meaningful step forward for clinicians seeking greater control in complex vascular procedures.

 “We look forward to making this technology available to physicians in the U.S. and supporting improved care for patients worldwide,” Cabiri said.

Data from GlobalData’s Medical Intelligence Center indicate that as of April 2024, sixteen neuro microcatheters were in various stages of development globally, with most expected to receive regulatory approvals within the next decade.

Further analysis reveals that the neuro microcatheter market is expanding at a compound annual growth rate (CAGR) of 5.4% and is projected to reach an estimated USD 792 million by 2034, up from USD 466.7 million in 2024.

This growth underscores the growing clinical demand for advanced, steerable devices such as the Bendit17 in interventional medicine.