FDA OKs BENDIT’s Steerable Microcatheter for Neuro, Coronary Vasculature

Steerable microcatheter maker BENDIT Technologies has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for it Bendit21 microcatheter to treat neurovascular, peripheral, and coronary vasculature. This followed successful first use of the Bendit21 neuro catheter in the U.S. in two procedures months ago.
 
The micocatheter features a steerable distal tip controlled with a “steering slider” on the proximal steering handle. The tip can be rotated bi-directionally by turning the steering handle’s torque knob. Bendit21 can be maneuvered with or without guidewires through all vasculatures.
 
“We already have FDA clearance for the peripheral indication. Now that we have received 510(k) clearance for the Bendit21, with expanded indications for neuro, coronary, and peripheral, endovascular specialists can begin utilizing the full potential of our steerable microcatheters,” Yossi Mazel, BENDIT’s CEO told the press. “We are planning a commercial release in the coming months in select medical institutions in the United States.”
 
Professor Alejandro Berenstein, MD, a Clinical Professor of Neurosurgery, Radiology and Pediatrics, and Director of the Pediatric Cerebrovascular Program at the Mount Sinai Health System in New York and board member at BENDIT added, “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.”
 
Rich Cappetta, Bendit chairman of the board, concluded, “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.”