New concept in neurovascular navigation: technical description and preclinical experience with the Bendit 17 and Bendit 21 microcatheters in a rabbit aneurysm model.

BACKGROUND: Endovascular treatment of intracranial vascular diseases, such as aneurysms, is often challenged by unfavorable vascular anatomy. The Bendit Steerable Microcatheter (Bendit Technologies, Tel Aviv, Israel) has bending and torqueing capabilities designed to improve navigation and stability during device delivery, with or without a guidewire. We describe our preclinical experience with the Bendit 17 and Bendit 21 microcatheters in a rabbit aneurysm model. METHODS: Bifurcation and side wall aneurysms were created surgically in six New Zealand rabbits. We attempted to navigate Bendit devices through the vasculature and enter the aneurysms without a guidewire. Various positions within the aneurysm were selectively explored. Angiographic imaging was used to visualize catheterization, navigation, vascular manipulations, and placement of coils, stents, and intrasaccular devices. RESULTS: We successfully navigated the Bendit microcatheters to all aneurysms without a guidewire. We successfully recanalized a nearly occluded carotid artery and navigated the Bendit through a braided stent. In contrast, we were unable to navigate a comparator device with a guidewire as effectively as the Bendit. Coils were introduced at different locations within the aneurysm and could be pushed, pulled, and repositioned with the Bendit tip. Finally, we used the Bendit to deliver intrasaccular devices designed for terminal aneurysms to treat side wall aneurysms. CONCLUSIONS: Bendit's bending and torqueing abilities, combined with its stability in the bent position, enable quick navigation and optimal deployment of devices. Clinical studies are necessary to determine whether these navigation advantages lead to more efficient treatment of intracranial and peripheral aneurysms.

Clinical experience with the Bendit steerable microcatheter: a new paradigm for endovascular treatment.

BACKGROUND: Vessel tortuosity poses a challenge during endovascular treatment of neurovascular lesions. Bendit Technologies (Petah Tikva, Israel) has developed flexible, steerable microcatheters designed with unique bending and torquing capabilities. OBJECTIVE: To describe our first-in-human trial of Bendit21. METHODS: Bendit21 was used in our exploratory, prospective, multicenter, open-label, single-arm clinical study, and in two compassionate use cases. Procedures were conducted at four centers in Austria, Germany, Israel, and the United States between May 2021 and March 2022, in patients with neurovascular conditions. The primary endpoints were device-related safety events, successful navigation through the neurovasculature, and, when intended, successful delivery of contrast or therapy. RESULTS: Two patients with giant aneurysms were treated successfully under compassionate use approval. The clinical study included 25 patients (mean age: 63.4±11.8 years; 32.0% female). Fourteen patients (56.0%) had aneurysms, two had arteriovenous malformations/fistulas (8.0%), one had a stroke (4.0%), four (16.0%) had intracranial stenosis, and four (16.0%) had other conditions. Bendit21 was used without a guidewire in 12/25 (48.0%) procedures. Bendit21 was successfully navigated through the vasculature without delays or spasms in all cases (100%). Contrast was delivered as intended in 7/7 (100%) cases. Therapeutic devices were delivered successfully with Bendit as intended in 14/18 (77.8%) cases; four deficiencies occurred in three patients with aneurysms, in whom delivery of coils, an intrasaccular device, or a flow diverter was attempted. There were no device-related safety events or mortalities. CONCLUSIONS: Our initial clinical experience with the Bendit21 microcatheter demonstrates its usefulness in achieving technical success in patients with challenging neurovascular conditions.