Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, April 19 2022 - 10:00
AsiaNet
BENDIT Technologies Receives U.S. Food and Drug Administration 510(k) Clearance of its Bendit 021" steerable microcatheter
TEL AVIV, Israel, April 19, 2022 /PRNewswire-AsiaNet/ --

BENDIT Technologies [ https://www.bendittech.com/ ], a company focused on the 
development of a steerable microcatheter platform, announced today that it has 
received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 
Bendit21 microcatheter for treatment in the neuro, peripheral, and coronary 
vasculature. The clearance was received several months after the successful 
first use of the Bendit21 neuro catheter in the USA in two life-saving 
procedures.

The Bendit21 Steerable Microcatheter is equipped with a steerable distal tip, 
controlled by a 'steering slider' on the proximal steering handle. Endovascular 
specialists can bi-directionally rotate the tip by simply turning the torque 
knob on the steering handle. These advanced steering and torqueability 
maneuvering capabilities are intended to enable navigation with or without 
guidewires, more precisely, and accurately, through all vasculatures, and 
potentially expanding indications, enhancing safety and saving procedure time.

"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," stated Yossi Mazel, BENDIT CEO. "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."

About BENDIT Technologies
BENDIT Technologies is a medical device company developing breakthrough 
technologies for steerable microcatheters, providing surgeons with 
3D-controlled bending and navigation capabilities. The company's patented 
technology reduces the complex catheterization procedure to a single step and 
enables quick and accurate outcomes. The company has previously received FDA 
clearance and CE Mark for the Bendit 2.7 microcatheter with an indication for 
peripheral use.

Visit www.bendittech.com.

Contact:
Yossi Mazel 
info@bendittech.com
 
Source: Bendit Technologies
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