Bendit’s 0.021-Inch Steerable Microcatheter Receives FDA 510(k) Clearance

April 18, 2022—Bendit Technologies, an Israel-based company focused on the development of a steerable microcatheter platform, announced it has received FDA 510(k) clearance for the Bendit21 microcatheter for treatment in the coronary, peripheral, and neuro vasculature.

According to the company, the Bendit21 steerable microcatheter is equipped with a steerable distal tip that is controlled by a steering slider on the proximal steering handle. Interventional specialists can bidirectionally rotate the tip by turning the torque knob on the steering handle.

The steering and torqueability maneuvering capabilities are intended to enable navigation with or without guidewires through all vasculatures, and potentially expanding indications, enhancing safety, and saving procedure time, stated Bendit.

Bendit noted that the clearance was received several months after the company announced the successful first use of the Bendit21 neuro catheter in the United States in two life-saving procedures.

The company has previously received FDA clearance and CE Mark approval for the Bendit 2.7 microcatheter with an indication for peripheral use.

Bendit CEO Yossi Mazel advised in the press release, “We already have FDA clearance for the peripheral indication. Now that we have received 510(K) clearance for the Bendit21, with expanded indications for neuro, coronary, and peripheral, endovascular specialists can begin utilizing the full potential of our steerable microcatheters. We are planning a commercial release in the coming months in select medical institutions in the United States.”

Professor Alejandro Berenstein, MD, a Clinical Professor of Neurosurgery, Radiology and Pediatrics, and Director of the Pediatric Cerebrovascular Program at the Mount Sinai Health System in New York, New York, commented, “The Bendit technology presents a transformative paradigm in endovascular navigation that will revolutionize the way we access the vasculature and will improve treatments throughout the arterial and venous systems, especially in the brain.” Dr. Berenstein is a board member at Bendit.