TruePath™ CTO Device

Indications, Safety, and Warnings

Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please 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 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, resulting 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 Extension Wire


The TruePath Extension Wire is designed to extend the TruePath CTO Device so that a catheter can be exchanged for another catheter.


None known.


Use prior to ‘Use By’ date.

Do not autoclave. Exposure to temperatures above 54°C (130°F) may damage the extension wire.

If strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding. If the cause of the resistance cannot be determined, withdraw the entire system.

If the polyimide tube at the distal end of the extension wire is damaged, do not use. Do not attempt to straighten a kinked polyimide tube. Replace the unit with an undamaged unit before proceeding.

The RVT Extension Wire is a non-patient contact component and should not be introduced into the support catheter.