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US FDA grants 510(k) clearance to Bendit Technologies’ Bendit 021 steerable microcatheter to treat neuro, peripheral, and coronary vasculature

Tel Aviv, Israel
Tuesday, April 19, 2022, 16:00 Hrs  [IST]

Bendit Technologies, a company focused on the development of a steerable microcatheter platform, announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Bendit21 microcatheter for treatment in the neuro, peripheral, and coronary vasculature. The clearance was received several months after the successful first use of the Bendit21 neuro catheter in the USA in two life-saving procedures.

The Bendit21 steerable microcatheter is equipped with a steerable distal tip, controlled by a 'steering slider' on the proximal steering handle. Endovascular specialists can bi-directionally rotate the tip by simply turning the torque knob on the steering handle. These advanced steering and torqueability maneuvering capabilities are intended to enable navigation with or without guidewires, more precisely, and accurately, through all vasculatures, and potentially expanding indications, enhancing safety and saving procedure time.

"We already have FDA clearance for the peripheral indication. Now that we have received 510K clearance for the Bendit21, with expanded indications for neuro, coronary and peripheral, endovascular specialists can begin utilizing the full potential of our steerable microcatheters," stated Yossi Mazel, Bendit CEO. "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 Paediatrics, and director of the Paediatric Cerebrovascular Programme at the Mount Sinai Health System in New York and board member at Bendit added, "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".

Rich Cappetta, Bendit chairman of the Board, concluded, "This is an important achievement for Bendit Technologies. The Bendit21 steerable catheter technology is a game-changer in endovascular medicine, and I would like to congratulate the Bendit team for their successes, paving the way for additional devices to add to the company's R&D pipeline."

Bendit Technologies is a medical device company developing breakthrough technologies for steerable microcatheters, providing surgeons with 3D-controlled bending and navigation capabilities.

 

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