VascularTube (beta) from the publishers of Endovascular Today TruePath™ CTO Device

Crossing Chronic Total Occlusions: Experiences with the TruePath™ CTO Device

Power forward with TruePath CTO Device

TruePath™ CTO Device

Rotating diamond-coated distal tip

TruePath™ is a powerful new solution for intraluminal treatment of chronic total occlusions. At 0.018″ in diameter, the guidewire- like profile is half the size of competitive offerings, designed for optimal steering and crossing. Once positioned, the self-rotating tip works effortlessly.

Prior to use, see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

The TruePath CTO Device is intended for use in native peripheral arteries.

INTENDED USE/INDICATIONS FOR USE: The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.

CONTRAINDICATIONS: The device is contraindicated for use in carotid arteries.

PRECAUTIONS: The TruePath CTO Device should only be used by physicians trained in percutaneous interventional techniques in a fully equipped catheterization laboratory. Do not use without completely reading and understanding the directions for use.

ADVERSE EVENTS: The risk and discomforts involved in treattment of chronic total occlusion include those associated with all peripheral vascular catheterization procedures. The following is a list of anticipated adverse events that may result from percutaneous transluminal peripheral intervention: Acute reclosure, Allergic reaction, Amputation, Aneurysm, Bleeding which may require transfusion or surgical intervention, Death, Dissection, Distal embolization, Excessive contrast loading in renal insufficiency or failure, Excessive exposure to radiation, Hematoma, Hypertension/Hypotension, Infection or fever, Ischemic events, Perforation, Peripheral artery bypass, Pseudoaneurysm or fistula, Repeat catheterization or angioplasty, Restenosis, Stroke/CVA, Thrombosis.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.