Bendit receives FDA 510(k) clearance for 0.021-inch steerable microcatheter

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Bendit Technologies has received US Food and Drug Administration (FDA) 510(k) clearance of 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 microcatheter in the USA in two life-saving procedures, according to a company press release.

“The Bendit technology presents a transformative paradigm in endovascular navigation that will revolutionise the way we access the vasculature, and will improve treatments throughout the arterial and venous systems, especially in the brain,” said Bendit board member Alejandro Berenstein (Mount Sinai Health System, New York, USA).

The press release states that the Bendit21 steerable microcatheter is equipped with a steerable distal tip, controlled by a ‘steering slider’ on the proximal steering handle. Endovascular specialists can bidirectionally rotate the tip by simply turning the torque knob on the steering handle. These advanced steering and ‘torqueability’ manoeuvring capabilities are intended to enable navigation with or without guidewires, more precisely, and accurately, through all vasculatures—potentially expanding indications, enhancing safety and saving procedure time.

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


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