TEL AVIV, Israel, April 19, 2022 /PRNewswire/ -- BENDIT
Technologies, 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
