Willow 24 Guidewire

The Willow 24 Guidewire is a single-use intravascular guidewire with a shapeable tip designed for general vascular access in neuro and peripheral procedures. It facilitates positioning and exchange of catheters and interventional devices in small diameter, tortuous blood vessels and is intended for use only by trained physicians.

The Willow 24 has the same core materials, design, and operating principles as the predicate Willow 18, including a nitinol tip, platinum-tungsten radiopaque coil, and proprietary hydrophilic coating. The key difference is a larger distal diameter of 0.024 inches (versus 0.018 inches on the predicate), and addition of a nitinol spacer component not present in the predicate.

Testing performed per FDA guidance 'Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling' (2019), ISO 14971:2019 (risk management), ISO 10993 series (biocompatibility), ISO 11135:2014 (ethylene oxide sterilization), and AAMI TIR28:2016(R)2024 (sterilization process equivalence).

The Willow 24 is substantially equivalent to the predicate Willow 18 based on identical indications for use, same fundamental materials and manufacturing processes, same design technology and operating principles, and same sterilization and packaging methods. Non-clinical bench testing and biocompatibility testing confirmed performance as intended with no new safety or effectiveness concerns; the larger distal diameter does not raise new questions of safety.