Image: Accessing the giant basilar tip aneurysm, PCA vessels exiting the aneurysm sac, using the Bendit21 (Photo courtesy of BENDIT Technologies)
A microcatheter platform with advanced steering and twisting maneuvering capabilities enables navigation with or without guidewires, more precisely and accurately, through all vasculature and potentially expanded indications, improving safety and enabling to save time.
The Bendit21 Steerable Microcatheter for the treatment of neuro, peripheral and coronary vessels from BENDIT Technologies (Tel Aviv, Israel) is equipped with a steerable distal tip, controlled by a “steering slider” on the proximal steering handle. Endovascular specialists can rotate the tip in either direction by simply turning the torque knob on the steering handle. The Company Received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for its Bendit21 Microcatheter for the Treatment of Neurological, Peripheral and Coronary Vascular System several months after the first successful use of the Bendit21 Neurological Catheter in the United States in two lifetimes. – backup of procedures.
“We already have FDA clearance for the peripheral indication. Now that we have received 510,000 approval for the Bendit21, with expanded neuro, coronary and peripheral indications, endovascular specialists can begin to utilize the full potential of our steerable microcatheters,” said Yossi Mazel, CEO of BEND IT. “We anticipate a commercial release in the coming months at select medical institutions in the United States.”
“Bendit technology presents a transformative paradigm in endovascular navigation that will revolutionize the way we access the vasculature and improve treatments throughout the arterial and venous systems, especially in the brain,” added Professor Alejandro Berenstein, MD, Clinical Professor of Neurosurgery. , Radiology and Pediatrics, and Director of the Pediatric Cerebrovascular Program at Mount Sinai Health System in New York and a member of the BENDIT Board of Directors.