OffRoad™

Re-entry Catheter System

OffRoad™ Re-entry Catheter System, designed for intuitive true lumen re-entry from subintimal space of the artery, is the industry’s most elegant dual-component solution for challenging lesions. Re-entry is intuitive as the 5.4 mm articulating Positioning Balloon directs the system, creating a path for the Micro-Catheter Lancet to re-enter the vessel with precision and ease.

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Product Details

  • Over-the-wire system
  • Unique 5.4 mm tipless Balloon anchors system
  • Platinum Iridium RO Marker intended to facilitate visualization of the balloon position

Dual-Component System

Positioning Balloon Catheter

Micro-Catheter Lancet

Positioning the OffRoad Balloon Catheters Positioning the OffRoad Balloon Catheters

Ordering Information

  Offroad Catheter – Short Offroad Catheter – Long
  H74939202070540
H74939202100540
Component Positioning
Balloon Catheter
Micro-Catheter Lancet Positioning
Balloon Catheter
Micro-Catheter Lancet
Length 70 cm 79 cm 100 cm 109 cm
Maximum Length of Micro-Catheter Lancet Extension Beyond Positiomimg Balloon 2 cm 2 cm
Catheter Shaft OD 5 F (1.33 mm) 2.4 F (0.85 mm) 5 F (1.33 mm) 2.4 F (0.85 mm)
Nominal Balloon Diameter 5.4 mm N/A 5.4 mm N/A
Radiopaque Marker Position Proximal Edge
of Balloon body
N/A Proximal Edge
of Balloon body
N/A
Nominal Inflation Pressure 2 ATM (203 kPA) N/A 2 ATM (203 kPA) N/A
Maximum Inflation Pressure 3.25 ATM (329 kPA) N/A 3.25 ATM (329 kPA) N/A
Sheath Diameter 6 F (1.33 mm) N/A 6 F (1.33 mm) N/A
Recommend Guidewire OD 0.035" (0.89 mm) 0.014" non-polymer coated 0.035" (0.89 mm) 0.014" non-polymer coated

Recommended Guidewire: Platinum PLUSᵀᴹ Guidewire

UPN/Ordner Code Length Diameter
M 001467120 180cm 0.014" (0.36 mm)
M 001467400 300 cm 0.014" (0.36 mm)

Case Studies

Re-ROUTE Clinical Study

Objective

To determine whether the OffRoad™ Re-entry Catheter System demonstrates acceptable performance in safety rates and device technical success for subintimal recanalization of a de novo or re-occluded chronic total occlusion (CTO) lesion in native femoropopliteal arteries

Overview

92-patient, prospective, single-arm, non-randomized, multi-center, post-market study conducted at 12 sites in Belgium, Germany and Switzerland.

Lesion Characteristics  
Mean length of Occlusion   
Mean Reference Vessel Diameter  
Calcification
None/Mild
Moderate
Severe

46.7%
47.8%
5.4%

End Point  Definition  Performance Goal All Patients (n=92) 
Primary Safety  Composite rate of major adverse events (MAEs) related to OffRoad™ System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)  MAE < 15%  MAE: 3.3%(3/87) 
Primary Effectiveness  Device technical success defined as placement of a guidewire in the true lumen distal to a CTO as confirmed by the angiography core lab.  Technical success > 76%  Technical Success: 84.8%(78/92) 
Additional Assessments  Average OffRoad System length of use time  N/A  11.1 minutes 
Average total fluoroscopy time  N/A  21.0 minutes 
Device-related perforation requiring intervention  N/A  0.00%

Clinical Summary

Re-ROUTE Study Summary

The Re-ROUTE results demonstrated that the OffRoadᵀᴹ Re-entry Catheter System is a valid treatment option for recanalization of femoropopliteal CTOs

  • OffRoad System facilitated placement of a guidewire in the true lumen distal to a CTO in over 84% of patients
  • OffRoad System had an average length of use time of ~11 minutes, demonstrating possible time savings associated with an access device
  • OffRoad System exhibited a 0.0% rate of device-related perforation requiring intervention

How-To

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