TruePath™

Chronic Total Occlusion Device (CTO) Device

TruePath CTO System
TruePath CTO System
DistalTip of the Truepath CTO Device
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TruePathTM  CTO Device
No capital equipment
Diamond-coated distal tip rotating at 13,000 rpm
TruePathTM CTO Device overview animation
Dr. James Park successfully crosses a 20cm CTO utilizing the TruePathTM CTO Device, guidewires, and a support catheter.
Case Study - Dr. Mustapha

A powerful new solution for intraluminal treatment of chronic total occlusions. At 0.018”/0 .46 mm in diameter, the guidewire-like profile is nearly half the size of competitive offerings, designed for optimal steering and crossing. Once positioned, the self-rotating tip works effortlessly.

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Product Details

TruePath: A Powerful new solution for intraluminal treatment of chronic total occlusions.

Power

  • Diamond-coated distal tip rotating at 13,000 rpm

Profile

  • 0.018”/0.46 mm guidewire-like profile, half the size of competitive offerings
  • Longest crossing device—165cm
  • Designed for optimal steering and crossing 

Ease of use

  • No capital equipment
  • 1:1 torque response
  • Audio and visual navigation aid in CTO navigation
  • Shapeable distal tip
  • Extension wire option, providing over 300 cm of working length for catheter exchange

TruePathᵀᴹ CTO-Device

Shaping Tool Motor Housing Control Unit
TruePath CTO Device System Details

Ordering Information

TruePathᵀᴹ CTO-Device
TruePathᵀᴹ CTO-Device
UPN Catalog No. Description
H74939208181650 39208-18165 TruePath CTO Device
H74939208001601 39208-00160 TruePath Extension Wires (5/box)
TruePathᵀᴹ Compatibility
Size (OD) Length Sheath Compatibility Min. Guide Catheter ID Tip Profile
0.018" / 0.46 mm 165 cm ≥ 0.018" / 0.46 mm compatible Catheters¹ ≥ 0.018" / 0.46 mm  0.017" / 0.43 mm

Clinical Information

ReOpen Study Objective

Demonstrate that TruePath CTO Device is safe and effective to facilitate crossing infrainguinal artery CTOs following resistance to crossing with a conventional guidewire or a prior failed attempt.
    - 85 Subjects
    - 3 centers in Europe
Key Clinical Results
  All Patients: (n=85)
Safety Endpoint  
Freedom from clinical perforation (any perforation requiring treatment) of the index lesion to 30 days 98.8% (*84/85)
   
Technical Success  
Facilitation of crossing the CTO with the TruePath CTO Device and/or any guidewire 80.0% (68/85)

Lesion Characteristics

Safe and Effective Use of TruePath CTO Device
Length of Occlusion < 100 mm 38.8%
  101 mm – 200 mm 30.6%
  201 mm – 450 mm 30.6%
     
Mean Length of Occlusion   166.0 mm

Case Studies

View Additional Case Studies:

CTO Case 1: Superficial Femoral Artery (SFA) Case
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CTO Case 2: Anterior Tibial
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CTO Case 3: Superficial Femoral Artery, 250 mm
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CTO Case 4: Restenosed Femoral Artery
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CTO Case 5: Anterior Tibial
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