Bendit Technologies has announced the successful first use in the USA of its Bendit21 neurocatheter in a life-saving treatment. The case was completed at the University of Texas Southwestern (UTSW) Medical Center and involved a 57-year-old female patient who had been suffering for years from an inoperable, symptomatic internal carotid artery aneurysm.
According to a company press release, the Bendit21 steerable microcatheter is designed to allow access to hard-to-reach vasculature locations with 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, the release adds.
John Barr, professor of Radiology and Neurological Surgery at UTSW Medical Center (Dallas, USA), used the Bendit21 device under compassionate use granted by the US Food and Drug Administration (FDA).
“We were pleased to be granted FDA approval for the compassionate use for this first case in the USA,” Barr said. “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.”
Yossi Mazel, CEO of Bendit, added: “This first-in-human case in the USA, together with other cases done in Israel and Europe, has demonstrated the potential of our steerable microcatheter to access torturous anatomies. This feature allows successful endovascular treatments in most complex situations and demonstrates how our catheter can ease access and intravascular navigation.”
According to the release, at this time, Bendit21 is not cleared or approved, and is not available for sale in the USA, European Union and other markets.