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.
