Bendit17 Microcatheter

The Bendit17 Microcatheter is a steerable microcatheter with an articulating distal tip designed for accessing small, tortuous vessels in the peripheral, coronary, and neuro vasculature. It is used to deliver diagnostic agents (such as contrast media) and therapeutic devices (such as coils, stents, and embolization particles) to target locations.

Compared to the predicate Bendit21, the Bendit17 has reduced outer diameter (2.7 Fr vs 3.1 Fr), inner diameter (0.017″ vs 0.021″), and effective length (151 cm vs 157 cm) to match competitor devices. The hydrophilic coating extends 100 cm distally versus 75 cm on the predicate. The deflecting section is slightly smaller (10 mm with 2 mm inner radius vs 12 mm with 3 mm radius). Both devices employ steering slider and torque knob controls with Nitinol coaxial tube construction.

Testing followed ISO 10555-1:2023 (intravascular catheters), ISO 80369-7:2021 and ISO 80369-20:2015 (Luer connectors), ISO 10993 series (biocompatibility), ISO 11135:2014 (ethylene oxide sterilization), USP methods for endotoxins and pyrogens, ASTM F756 (hemolysis), and GLP-compliant animal studies in porcine models.

The Bendit17 has identical indications for use, operational mechanism, and design principles as the predicate Bendit21. Dimensional reductions and extended hydrophilic coating do not introduce new safety or effectiveness concerns and align the device with industry standards. Comprehensive bench testing, animal studies in tortuous neurovascular models, and biocompatibility testing demonstrate performance equivalent to the predicate and reference devices.