The 510K clearance will allow Bendit Technologies to commercially release the microcatheter in upcoming months in medical institutions in the US
Israel-based Bendit Technologies has received US Food and Drug Administration (FDA) 510(k) clearance for its Bendit21 microcatheter.
The microcatheter is intended for use in the treatment of the neuro, peripheral, and coronary vasculature.
FDA granted the clearance after the successful use of Bendit21 neuro catheter in the US in two life-saving procedures.
The Bendit21 Steerable Microcatheter has a steerable distal tip that is activated by a ‘steering slider’ on the proximal steering handle.
Endovascular doctors can move the tip in both directions by moving the torque knob on the steering lever.
The company said that the improved steering and torqueability manoeuvring capabilities are expected to provide more precise and accurate navigation with or without guidewires through all vasculatures, thereby increasing indications, improving safety, and decreasing procedure time.
Bendit Technologies chief executive officer Yossi Mazel said: “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 utilising 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.”
Bendit board member professor Alejandro Berenstein said: “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.”
Bendit board chairman Rich Cappetta said: “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.”
The company already has FDA clearance for peripheral indications.