BackgroundEndovascular 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.MethodsBifurcation 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.ResultsWe 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.ConclusionsBendit’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.
BackgroundVessel 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.ObjectiveTo describe our first-in-human trial of Bendit21.MethodsBendit21 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.ResultsTwo 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.ConclusionsOur initial clinical experience with the Bendit21 microcatheter demonstrates its usefulness in achieving technical success in patients with challenging neurovascular conditions.
Unfavorable vascular anatomy poses a challenge to endovascular navigation when treating neurovascular diseases. To address this, Bendit Technologies developed the Bendit21 articulating/steerable microcatheter with bending and torquing capabilities that improve navigability and stability during device delivery. The Bendit21 has an outer diameter of 3.1 Fr (0.041 00 ), an inner diameter of 0.021 00 , and shaft length of 157 cm. It is compatible with guidewires up to 0.018 00 . We describe a series of our clinical and simulated experiences using Bendit devices to successfully navigate difficult vascular scenarios. The participants and any identifiable individuals consented to publication of his/her image, and the patients consented to the procedures. The accompanying video describes the uses of the Bendit21 catheter, now approved by the FDA. We demonstrate the use of the Bendit microcatheter to traverse a tortuous vertebral artery. Although it can be used in conjunction with a guidewire, it was used in another case to wirelessly bypass the ophthalmic artery to reach the A1 segment of the anterior cerebral artery. The device was also effective in traversing a vertebral artery stent which was located distally, making access challenging. The Bendit was used to effectually treat 2 cases of aneurysms in which all previous treatment attempts had failed. In addition, the Bendit microcatheter accurately delivered an intrasaccular device into an anterior communicating artery aneurysm and was also successfully implemented in the treatment of a dural arteriovenous malformation through the cortical veins. We show that the Bendit articulating/steerable microcatheter allows unique navigability, and precise, stable positioning can be critical advantages in the treatment of various intracranial vascular lesions.
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