Bendit Technologies Achieves FDA Clearance for Bendit17™ Microcatheter

Bendit Technologies Announces FDA Clearance for Bendit17™ Microcatheter

Bendit Technologies has made an important leap forward in endovascular care with the recent announcement of receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest innovation, the Bendit17™ microcatheter. This microcatheter stands out as the smallest steerable device available, marking a significant development in precision and accessibility within neurovascular and peripheral endovascular interventions.

The FDA clearance is crucial, granting Bendit the ability to introduce this groundbreaking technology to healthcare professionals and patients throughout the United States. The company is in the final stages of production and is gearing up to launch its first commercial clinical procedures starting January 2026. In addition to its U.S. efforts, Bendit is actively seeking regulatory approvals in various international markets, aiming to extend the benefits of the Bendit17™ globally.

Oz Cabiri, CEO of Bendit Technologies, stated that the FDA clearance symbolizes a pivotal achievement for the team and a major enhancement for clinicians aiming for greater control and navigational precision in complex vascular procedures. He emphasized that the Bendit17™ represents a substantial technological advancement, particularly due to its capability to navigate both with and without a guidewire. Cabiri's vision reflects the company's mission: to continuously push the boundaries of possibilities in endovascular care.

The Bendit17™ microcatheter introduces an unprecedented level of steerability and precision, making it essential for controlled navigation through complex anatomical structures. This innovative device ensures that clinicians can maintain stability while navigating intricate vascular landscapes, ultimately enhancing ease of use and clinical outcomes. Designed with a range of challenging vascular procedures in mind, its functionalities empower clinicians to perform procedures more efficiently.

Bendit Technologies specializes in developing advanced steerable microcatheters that focus on improving accuracy, accessibility, and overall patient care through minimally invasive endovascular techniques. The proprietary technology employed by Bendit enables real-time three-dimensional steering capabilities, enhancing navigability during complex procedures. This not only empowers healthcare providers but also aims at significantly improving patient outcomes, pushing the field's technological envelopes.

As the launch date approaches, clinicians and hospitals across the country can anticipate the arrival of the Bendit17™ microcatheter, believing it could become an indispensable tool in their medical arsenal as they tackle increasingly complex vascular challenges. The reception of this innovative product is highly anticipated, with expectations set that it will redefine standards in minimally invasive procedures.

In conclusion, the FDA clearance of the Bendit17™ microcatheter heralds a new era in endovascular interventions, signifying not only technological advancement but also the commitment to improving patient care worldwide. With production ramping up and clinical applications on the horizon, Bendit Technologies is poised to lead the way in transforming how vascular procedures are approached today and in the future.

Bendit17™ Microcatheter