Willow 18 Guidewire

The Willow 18 Guidewire is a single-use intravascular device with a shapeable tip used to gain access and position catheters and interventional devices in small-diameter, tortuous blood vessels in the neuro and peripheral vasculature. It is available in two stiffness profiles (Soft and Standard) and comes with accessories including introducers, a torque device, and a shaping mandrel. The device is intended for use only by physicians trained in percutaneous, intravascular techniques.

The subject device matches the predicate in core wire materials (metal alloy with PTFE coating), guidewire tip (laser-cut nitinol), radiopaque coil (platinum-tungsten), adhesives, primer, hydrophilic coating, and sterilization method (100% ethylene oxide). Key difference: the subject device is larger in overall diameter, includes two guidewire introducers instead of one, and adds cyanoacrylate adhesive in addition to UV-curable adhesive.

Bench testing followed FDA's 2019 guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling." Biocompatibility testing referenced ISO 10993 standards (parts 4, 5, 10, 11). Risk assessment conducted per ISO 14971:2019. Sterilization validation per ISO 11135:2014.

The Willow 18 Guidewire is substantially equivalent to the 0.014" Willow Guidewire predicate device because both share identical indications for use, same fundamental materials and manufacturing processes, same design and operating principles, and same packaging and sterilization methods. Non-clinical bench and biocompatibility testing demonstrated the subject device performs as intended with no new safety or effectiveness questions raised by the larger diameter design change.