X-Wire Guidewire

The X-Wire Guidewire is a shapeable-tip guidewire intended for general intravascular use in peripheral and neuro vasculature to introduce and position catheters and other interventional devices. It is not intended for coronary use. Available in three diameters (0.014", 0.018", 0.024"), two stiffness profiles (standard and support), and lengths of 200–300 cm, with hydrophilic distal and PTFE proximal coatings for reduced friction.

The X-Wire shares the same core-to-tip shapeable design, nitinol distal tip material, stainless steel core, radiopaque markers, and dual-coating strategy as the predicate Aristotle guidewires. Key differences include variable tip lengths and hydrophilic coating lengths across the three diameter variants, a shorter radiopaque marker length (8.5 cm vs. 10 cm), and different numbers of centering coils per variant. Shelf life is 8 months compared to the predicate's 36 months or 4 months.

Testing was based on FDA's October 2019 guidance on Coronary, Peripheral, and Neurovascular Guidewires. Biocompatibility per ISO 10993 (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, thromboresistance). Sterilization validated per ISO 11135 (ethylene oxide). Shelf life and packaging per ASTM F1980.

The subject device has identical intended use and regulatory classification to the predicates. Comprehensive bench testing—including torqueability, tip flexibility, tensile strength, kink resistance, coating integrity, and simulated use—demonstrated that dimensional and design differences (variable tip lengths, coating lengths, centering coil counts) do not negatively impact safety or performance parameters. Biocompatibility and hemocompatibility testing confirmed the device is safe for ≤24-hour blood contact. The differences do not raise new questions of safety or effectiveness, supporting substantial equivalence.