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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.

Visible Confidence

See what you’ve been missing….
  • Predictable Deployment
  • Visible Results

EX.P.R.T™ Release Technology
  • Essentially eliminates premature deployment or jumping

    Protege RX Carotid Stent System

Tantalum GPS™ Markers / Tapered Stent Design
  • Enhanced visibility for precise positioning and result confirmation
  • Unique anatomically designed tapered stent for better fit the carotid bifurcation

FOOTNOTES
* The safety and efficacy of the Protege™ RX Carotid Stent System in the carotid indication has not been demonstrated with embolic protection devices other than with the ev3 Inc. Spider OTW Embolic Protection Device. The SpideRX™ Embolic Protection Device has been demonstrated to be compatible with the PROTÉGÉ RX Carotid Stent System in bench and animal testing. SpiderFX™ Embolic Protection Device is the next generation to the SpideRX Embolic Protection Device.

The clinical data contained within this document reflects data generated using the PROTÉGÉ GPS Carotid Stent System but has been determined to be applicable to the Protege RX Carotid Stent System in bench and animal testing.

** Defined as successful deployment and retrieval of distal protection device, successful stent deployment and final diameter stenosis < 50%.
For additional product information please contact your regional sales representative.
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

For additional product information please contact your regional sales representative.

The PROTÉGÉ RX Stent is CE marked for use in the iliac or subclavian arteries and in the palliative treatment of malignant neoplasms in the biliary tree. It is also indicated for treatment of stenoses of the common carotid artery (CCA), internal carotid artery (ICA) and carotid bifurcation.
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.