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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.

Predictable Deployment
  • Proprietary EX.P.R.T.™ Release Technology essentially eliminates premature deployment or jumping
  • No stent shortening
  • Unique anatomically designed tapered stent for better fit in the carotid bifurcation
  • 0.014" rapid exchange catheter with 6F low crossing profile and flexible atraumatic tip
  • Radiopaque marker on catheter clearly indicates tapered location for precise positioning
Protege RX Carotid Stent System


Visible Results
  • Tantalum GPS™ markers enhance visibility for precise positioning and result confirmation
  • Cell design produces expansion force that resists compression while providing excellent wall apposition
  • Straight and tapered options for customzed fit in carotid vessels

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 Protege 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 Protege 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%.
Product Spec
         

Straight
Model Number Diameter(mm) Length(mm) Lumen Size(mm)
SECX-6-20-135 6 20 4.5-5.5
SECX-7-20-135 7 20 5.5-6.5
SECX-8-20-135 8 20 6.5-7.5
SECX-9-20-135 9 20 7.5-8.5
SECX-10-20-135 10 20 8.5-9.5
SECX-6-30-135 6 30 4.5-5.5
SECX-7-30-135 7 30 5.5-6.5
SECX-8-30-135 8 30 6.5-7.5
SECX-9-30-135 9 30 7.5-8.5
SECX-10-30-135 10 30 8.5-9.5
SECX-6-40-135 6 40 4.5-5.5
SECX-7-40-135 7 40 5.5-6.5
SECX-8-40-135 8 40 6.5-7.5
SECX-9-40-135 9 40 7.5-8.5
SECX-10-40-135 10 40 8.5-9.5
SECX-6-60-135 6 60 4.5-5.5
SECX-7-60-135 7 60 5.5-6.5
SECX-8-60-135 8 60 6.5-7.5
SECX-9-60-135 9 60 7.5-8.5
SECX-10-60-135 10 60 8.5-9.5

Tapered
Model Number Diameter(mm) Length(mm) Lumen Size(mm)
SECX-8-6-30-135 8/6 30 (6.5-7.5)-(4.5-5.5)
SECX-8-6-40-135 8/6 40 (6.5-7.5)-(4.5-5.5)
SECX-10-7-30-135 10/7 30 (8.5-9.5)-(5.5-6.5)
SECX-10-7-40-135 10/7 40 (8.5-9.5)-(5.5-6.5)

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:

 

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.