OffRoad™

Re-entry Catheter System

OffRoad Re-entry Catheter System is an elegant solution for challenging lesions. Designed for precision and ease of use, a Positioning Balloon makes re-entry intuitive by directing a Micro-Catheter lancet to re-enter the artery.

Key Resources

Indications, Safety, and Warnings

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Product Details

Features and Benefits

  • 6 F sheath compatible catheter system tracks over 0.035" guidewires
  •  5.4 mm conical Positioning Balloon designed to direct the Micro-catheter Lancet
  • Flexible balloon neck allows for natural rotation toward true lumen
  • Micro-catheter Lancet accommodates the passage of 0.014“guidewires
  • Lancet tip designed to facilitate re-entry

Dual-Component System

Ordering Information

OffRoad Re-entry Catheter-Short (70 cm)

UPN # Component Positioning Balloon Catheter Micro-Catheter Lancet
  Length 70 cm 79 cm
  Maximum Length of Micro-Catheter Lancet Extension Beyond Positioning Balloon 2 cm 2 cm
  Catheter Shaft OD  5 F 2.4 F
H74939202070540 Nominal Balloon Diameter 5.4 mm N/A
  Nominal Inflation Pressure 2 ATM N/A
  Maximum Inflation Pressure 3.25 ATM N/A
  Sheath Diameter 6 F NA
  Recommended Guidewire OD 0.035" 0.014"  (Non-Polymer Coated)

OffRoad Re-entry Catheter-Long (100 cm)

UPN # Component Positioning Balloon Catheter Micro-Catheter Lancet
  Length 100 cm 109 cm
  Maximum Length of Micro-Catheter Lancet Extension Beyond Positioning Balloon 2 cm 2 cm
  Catheter Shaft OD  5 F 2.4 F
H749392020100540 Nominal Balloon Diameter 5.4 mm N/A
  Nominal Inflation Pressure 2 ATM N/A
  Maximum Inflation Pressure 3.25 ATM N/A
  Sheath Diameter 6 F NA
  Recommended Guidewire OD 0.035" 0.014"  (Non-Polymer Coated)

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  175.1 ± 85.42 mm
Mean Reference Vessel Diameter 5.18 ± 0.62 mm
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%(3/90) 
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%

Recommended Non-Polymer Coated Guidewires

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