Bendit Technologies receives FDA Clearance for steerable Bendit17 Microcatheter

Bendit Technologies said the U.S. Food and Drug Administration has granted 510(k) clearance for the Bendit17 Microcatheter, clearing the way for the device to enter the U.S. market as the smallest steerable microcatheter available.

The company said the clearance marks “a significant step forward in advancing precision and accessibility in neurovascular and peripheral endovascular interventions.” Bendit is completing final production and plans to begin its first U.S. commercial clinical procedures in January 2026. The company is also seeking regulatory approvals in additional global markets.

“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,” said Oz Cabiri, CEO of Bendit Technologies. “The device's capability to navigate with or without a guidewire represents a significant technological leap forward. Our mission is to push the boundaries of what is possible in endovascular care, and the Bendit17 embodies that vision. We look forward to bringing this technology available to physicians in the U.S. and supporting improved care for patients worldwide.”

The catheter is designed to offer high-level steerability and precise navigation through complex anatomies while maintaining stability and ease of use, according to the company. Bendit said its unique design aims to support a wide range of intricate vascular procedures.

Recent developments in endovascular and neurovascular device innovation

The endovascular and neurovascular device sectors have undergone rapid evolution in recent years, driven by rising procedural volumes, a shift toward minimally invasive care and continued refinements in microcatheter, guidewire and embolization technologies. One of the most notable trends is the push toward smaller, more navigable devices capable of reaching challenging anatomy once considered inaccessible. This includes ultra-low-profile catheters, enhanced hydrophilic coatings and steerable systems that allow operators greater control during tortuous navigation.

Steerability has emerged as a defining area of innovation. Traditional microcatheters rely heavily on guidewires for navigation, but new technologies—including Bendit’s platform and competing articulating or torque-responsive systems—aim to reduce dependence on guidewires and improve procedural efficiency. These capabilities are particularly important in neurovascular work, where millimeter-scale precision can determine outcomes in stroke treatment, aneurysm care and arteriovenous malformation management.

Another major shift involves integrating improved material science. Braided and laser-cut hypotube technologies, shape-lockable catheters and more durable polymers have increased pushability, kink resistance and stability. At the same time, companies are developing catheters that can deliver a broader range of therapeutic devices, including intrasaccular flow disruptors, soft coils and targeted drug-delivery systems.

Regulatory momentum has also accelerated innovation. The FDA has advanced programs to support novel stroke-care technologies, including expedited pathways for thrombectomy and next-generation access tools. Many device makers are introducing systems tailored for distal vessel navigation, reflecting growing clinical interest in treating smaller, harder-to-reach cerebral vessels.

Together, these advancements reflect a rapidly maturing sector focused on precision, safety and expanding the range of treatable vascular conditions through minimally invasive intervention.