Bendit Technologies today announced it received FDA 510(k) clearance for its Bendit21 microcatheter.
The Israel-based company’s microcatheter is indicated for use in the treatment of the neuro, peripheral and coronary vasculature. The Bendit21 was granted clearance several months after the successful first use of the neurocatheter in the U.S.
“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,” CEO Yossi Mazel said in a news release. “We are planning a commercial release in the coming months in select medical institutions in the United States.”
Bendit21 is a steerable microcatheter equipped with a steerable distal tip and controlled by a steering slider on the proximal steering handle. Physicians can bi-directionally rotate the tip by turning a torque knob on the steering handle, according to the company. Bendit Technologies designed the microcatheter to enable navigation with or without guidewires through all vasculatures.
“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,” said Alejandro Berenstein, director of the pediatric cerebrovascular program at Mount Sinai Health System in New York and Bendit board member.
