BENDIT Technologies Receives U.S. Food and Drug Administration 510(k) Clearance of its Bendit 021" steerable microcatheter
PR95521
TEL AVIV, Israel, April 19, 2022 /PRNewswire=KYODO JBN/ --
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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