Search Results

The IVT 0.014" TRACK is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.

The IVT 0.014" TRACK is constructed from Aermet 100 steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible. The core is nominally 0.0136" in diameter. The coil, approximately 1.2" in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. The core is inserted into the coil lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb. This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core using a silver alloy solder. The IVT 0.014" TRACK will be manufactured in various lengths ranging from 100 to 300 cms. All IVT 0.014" TRACKs will receive a final parylene (poly-para-xylyene) coating prior to packaging and sterilization. Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the IVT 0.014" TRACK allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.

This document concerns a medical device (guidewire) and does not contain information about an AI/ML powered device, a study that uses a test set, or human/expert evaluations. Therefore, I cannot provide the requested information about acceptance criteria and study details.

Ask a specific question about this device