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Classified in: Health, Science and technology
Subject: FDA

SUCCESSFUL FIRST-IN-HUMAN USE OF BENDIT21 NEUROVASCULAR CATHETER PERFORMED AT THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER


TEL AVIV, Israel, Jan. 20, 2022 /PRNewswire/ -- BENDIT Technologies, a company focused on the development of steerable microcatheters, announced today the successful first use in the USA of the BENDIT21 neuro catheter in a life-saving treatment. The case involved a 57-year-old female patient who had been suffering for years from an inoperable symptomatic internal carotid artery aneurysm.

The BENDIT steerable microcatheter is designed to allow access to hard-to-reach vasculature locations due to its three-dimensional clinician-controlled movement and independent control of catheter tip deflection. These advanced capabilities are intended to enable surgeons to navigate quickly and precisely through the neuro, peripheral and coronary vasculature.

Dr. John Barr, Professor of Radiology and Neurological Surgery, UT Southwestern Medical Center, used the BENDIT21 steerable microcatheter under compassionate use granted by the FDA.

"We were pleased to be granted FDA approval for the compassionate use for this first case in the U.S. Previous access attempts had failed both here at UT Southwestern and at an outside facility because the neck of the giant aneurysm could not be crossed using other catheters," said Dr. John Barr.

Yossi Mazel, CEO of the Petach Tikva-based medical device company added, "This first-in-human case in the US together with other cases done in Israel and Europe, has demonstrated the potential of our steerable microcatheter to access torturous anatomies. He concluded, "This feature allows successful endovascular treatments in most complex situations and demonstrates how our catheter can ease access and intra vascular navigation."

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 for peripheral vascular, neurovascular, and coronary indications. The company's patented technology reduces the complex catheterization procedure to a single step and enables quick and accurate outcomes. BENDIT Technologies has already received FDA clearance and CE Mark for the company's first microcatheter with an indication for peripheral use and is in the submission process for the BENDIT21 microcatheter for the neurovascular, peripheral, and coronary indications.

At this time BENDIT21 is not cleared / approved and is not available for sale in US, EU and other markets.

Visit www.bendittech.com.
For more information, please contact:
Yossi Mazel
[email protected]

 

SOURCE Bendit Technologies


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