TruePath™ CTO Device

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

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

The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.

The device is contraindicated for use in carotid arteries.

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.

The risk and discomforts involved in treatment 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.

TruePath is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates.