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Protege® RX Carotid Stent System

Predictable Deployment, Visible Results

The Protege® RX Carotid Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The stent is designed to hold plaque against the arterial wall, open up the blood vessel, and prevent a stroke from occurring. It is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6F, 0.014” rapid exchange delivery system. The stent is cut from a Nitinol tube in an open lattice design, and is designed with tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency of the vessel.

EX.P.R.T™ Release Technology
  • Essentially eliminates premature deployment or jumping
  • Enhanced visibility for precise positioning and result confirmation
  • Unique anatomically designed tapered stent for better fit the carotid bifurcation

    Protege RX Carotid Stent System
Straight
Model number Stent Length (mm) Diameter (mm) Lumen Size (mm) Sheath Compatibility (F)
CNSECX-6-20-135 20 6 4.5-5.5 6/8
CNSECX-7-20-135 20 7 5.5-6.5 6/8
CNSECX-8-20-135 20 8 6.5-7.5 6/8
CNSECX-9-20-135 20 9 7.5-8.5 6/8
CNSECX-10-20-135 20 10 8.5-9.5 6/8
CNSECX-6-30-135 30 6 4.5-5.5 6/8
CNSECX-7-30-135 30 7 5.5-6.5 6/8
CNSECX-8-30-135 30 8 6.5-7.5 6/8
CNSECX-9-30-135 30 9 7.5-8.5 6/8
CNSECX-10-30-135 30 10 8.5-9.5 6/8
CNSECX-6-40-135 40 6 4.5-5.5 6/8
CNSECX-7-40-135 40 7 5.5-6.5 6/8
CNSECX-8-40-135 40 8 6.5-7.5 6/8
CNSECX-9-40-135 40 9 7.5-8.5 6/8
CNSECX-10-40-135 40 10 8.5-9.5 6/8
CNSECX-6-60-135 60 6 4.5-5.5 6/8
CNSECX-7-60-135 60 7 5.5-6.5 6/8
CNSECX-8-60-135 60 8 6.5-7.5 6/8
CNSECX-9-60-135 60 9 7.5-8.5 6/8
CNSECX-10-60-135 60 10 8.5-9.5 6/8

Tapered
Model number Stent Length (mm) Diameter (mm) Lumen Size (mm) Sheath Compatibility (F)
CNSECX-8-6-30-135 30 8/6 (6.5-7.5)-(4.5-5.5) 6/8
CNSECX-8-6-40-135 40 8/6 (6.5-7.5)-(4.5-5.5) 6/8
CNSECX-10-7-30-135 30 10/7 (8.5-9.5)-(5.5-6.5) 6/8
CNSECX-10-7-40-135 40 10/7 (8.5-9.5)-(5.5-6.5) 6/8
The Protege RX Carotid Stent System, when used in conjunction with ev3 embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the criteria outlined below:

1. Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography) of the common or internal carotid artery, AND
2. Patients must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral and peripheral vasculature.
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.  CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Essential Prescribing Information (EPI): The PROTÉGÉ RX Carotid Stent System, when used in conjunction with the ev3 embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the following criteria: 1. Patients with carotid artery stenosis (>50% for symptomatic patients by ultrasound or angiography or >80% for asymptomatic patients by ultrasound or angiography) of the Common or Internal Carotid Artery, AND 2. Patients must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion. 

CONTRAINDICATIONS: Use of the PROTÉGÉ RX Carotid Stent System is contraindicated under these circumstances: Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs is contraindicated; patients with vascular tortuosity or anatomy, which precludes the safe introduction of the sheath, guide catheter, embolic protection system, or stent system; patients with known hypersensitivity to nickel-titanium; patients with uncorrected bleeding disorders; lesions in the ostium of the common carotid artery. 

WARNING: Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.