Steerable microcatheter nets FDA 510(k) clearance for neurologic, peripheral, coronary use
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Bendit Technologies announced it received FDA 510(k) clearance for its steerable microcatheter platform for treatment in the neurologic, peripheral and coronary vasculature.
According to a company press release, the clearance was received several months after the first successful use of its neuro catheter (Bendit21) in the U.S. in two lifesaving procedures.
The microcatheter features a steerable distal tip, controlled by a 'steering slider' on a proximal steering handle. These maneuvering capabilities are designed to enable navigation with or without guidewires through all vasculatures, according to the release.
"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," Alejandro Berenstein, MD, clinical professor of neurosurgery, radiology and pediatrics, and director of the pediatric cerebrovascular program at the Mount Sinai Health System in New York, said in the release.
The company is planning a commercial release in the coming months in select U.S. medical institutions.
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