Bendit’s Neurovascular Catheter Used in First-in-Human Procedure

January 20, 2022—Bendit Technologies, a developer of steerable microcatheters based in Petach Tikva, Israel, announced the successful first use in the United States of the Bendit21 neurocatheter in a life-saving treatment.

The case involved a female patient in her late 50s who for years had an inoperable symptomatic internal carotid artery aneurysm. John Barr, MD, used the Bendit21 steerable microcatheter under compassionate use granted by the FDA. Dr. Barr is Professor of Radiology and Neurological Surgery at University of Texas Southwestern Medical Center, in Dallas, Texas.

According to the company, 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 capabilities are intended to enable surgeons to navigate quickly and precisely through the neuro, peripheral, and coronary vasculature.

Currently, Bendit21 is not cleared or approved and is not available for sale in the United States, the European Union, and other markets. The company advised it is in the submission process for the Bendit21 microcatheter for the neurovascular, peripheral, and coronary indications.

“We were pleased to be granted FDA approval for the compassionate use for this first case in the United States,” commented Dr. Barr in Bendit’s press release. “Previous access attempts had failed both here at University of Texas Southwestern and at an outside facility because the neck of the giant aneurysm could not be crossed using other catheters.”

Bendit Technologies is developing breakthrough technologies for steerable microcatheters, that provide three-dimensional controlled bending and navigation capabilities for peripheral vascular, neurovascular, and coronary indications. The company’s technology reduces the complex catheterization procedure to a single step and enables quick and accurate outcomes, stated the company.

Bendit Technologies has received FDA clearance and CE Mark approval for the company’s first microcatheter with an indication for peripheral use.

Yossi Mazel, CEO of Bendit Technologies, stated, “This first-in-human case in the United States 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.”