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.
Explore
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
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
