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.”