Israeli medical device company, Bendit Technologies received 510(k) clearance from the US Food and Drug Administration for its flagship steerable Bendit21 microcatheter device, the company announced this week.
News of the clearance came several months after the Bendit neuro catheter was used for the first in two life-saving procedures in the US.
The Bendit21 Steerable Microcatheter “is equipped with a steerable distal tip, controlled by a ‘steering slider’ on the proximal steering handle,” the company said in the announcement, noting that the “advanced steering maneuverability enables endovascular specialists the ability to more precisely navigate all vasculatures, reducing procedure durations, improving safety, and opening the door to additional applications.”
Founded in 2013, Bendit Technologies is a medical device firm developing technologies for steerable microcatheters. The company’s patented tech provides surgeons with 3D-controlled bending and navigation capabilities, which helps reduce complex catheterization procedures to a single step.
The company has previously received FDA clearance and CE Mark for the Bendit 2.7 microcatheter with an indication for peripheral use.
“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,” said Yossi Mazel, CEO of Bendit. “We are planning a commercial release in the coming months in select medical institutions in the United States.”
“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 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.
Rich Cappetta, Bendit chairman of the board, added that 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.”