Medtronic Stedi Extra Support Guidewire

The Medtronic Stedi Extra Support Guidewire is a 0.035-inch diameter, 275 cm long catheter guide wire made of stainless steel with a PTFE coating. It is designed to introduce and position catheters during interventional heart procedures, including transcatheter aortic valve replacement (TAVR), and is sterilized with ethylene oxide for single use.

The Stedi Guidewire has the same core design principles as the predicate (Medtronic Confida Brecker Guidewire) but incorporates design modifications including different coil shape, dimensional characteristics (tip sizes of 3cm or 4cm, proximal wire diameter, wire length), coating process, bonding type (proximal bond and distal weld), and materials used at the proximal joint.

ISO 11135 (sterilization validation), ISO 10993-1 (biocompatibility testing including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, and thrombogenicity), ISO 11607 (packaging design verification), and FDA guidance on Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019).

The Stedi Guidewire shares the same intended use and principles of operation as the predicate device and demonstrates substantially equivalent functional characteristics through identical materials (stainless steel), similar construction methods, and comparable dimensions. Comprehensive performance and safety testing—including tensile strength, torque, lubricity, kink resistance, flex and fracture testing, and full biocompatibility evaluation—showed that all design modifications do not raise new safety or efficacy questions and the device continues to meet its intended use.