Healthcare Professionals

Protégé RX Carotid Stent 

Vascular Stenting

Overview

Select the Protégé™ RX self-expanding carotid stent system, in straight or tapered models, for custom fit in carotid arteries when stenting procedures are indicated. Tantalum GPS markers enhance visibility for precise positioning and result confirmation.


U.S. Indications

The Protégé RX Carotid Stent System, when used in conjunction with the ev3 embolic protection system, 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.


Product Details

Predictable Deployment

  • Proprietary EX.P.R.T.™ release technology essentially eliminates premature deployment or jumping.
  • There's no stent shortening.
  • Unique anatomically designed tapered stent for better fit in the carotid bifurcation.
  • Offers 0.014" rapid exchange catheter with 6 F low crossing profile and flexible atraumatic tip.
  • Radiopaque marker on catheter clearly indicates tapered location for precise positioning.

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 customized fit in carotid vessels.

Manuals and Technical Guides

Instructions for Use
Find this technical manual in the product labeling supplied with each device or by calling technical support for cardiovascular services: (877) 526-7890.


MODEL SPECIFICATIONS

Reference Number Unconstrained
Stent Diameter
(mm)
Unconstrained
Stent Length
(mm)
Recommended
Lumen Size
(mm)
Usable
Catheter Length
(cm)
Sheath Size
(F)
Guidewire
Acceptance
(in)
Straight
SECX-6-20-135 6 20 4.5-5.5 135 6 0.014
SECX-6-30-135 6 30 4.5-5.5 135 6 0.014
SECX-6-40-135 6 40 4.5-5.5 135 6 0.014
SECX-6-60-135 6 60 4.5-5.5 135 6 0.014
SECX-7-20-135 7 20 5.5-6.5 135 6 0.014
SECX-7-30-135 7 30 5.5-6.5 135 6 0.014
SECX-7-40-135 7 40 5.5-6.5 135 6 0.014
SECX-7-60-135 7 60 5.5-6.5 135 6 0.014
SECX-8-20-135 8 20 6.5-7.5 135 6 0.014
SECX-8-30-135 8 30 6.5-7.5 135 6 0.014
SECX-8-40-135 8 40 6.5-7.5 135 6 0.014
SECX-8-60-135 8 60 6.5-7.5 135 6 0.014
SECX-9-20-135 9 20 7.5-8.5 135 6 0.014
SECX-9-30-135 9 30 7.5-8.5 135 6 0.014
SECX-9-40-135 9 40 7.5-8.5 135 6 0.014
SECX-9-60-135 9 60 7.5-8.5 135 6 0.014
SECX-10-20-135 10 20 8.5-9.5 135 6 0.014
SECX-10-30-135 10 30 8.5-9.5 135 6 0.014
SECX-10-40-135 10 40 8.5-9.5 135 6 0.014
SECX-10-60-135 10 60 8.5-9.5 135 6 0.014
Tapered
SECX-8-6-30-135 8/6 30 (6.5-7.5)-(4.5-5.5) 135 6 0.014
SECX-8-6-40-135 8/6 40 (6.5-7.5)-(4.5-5.5) 135 6 0.014
SECX-10-7-30-135 10/7 30 (8.5-9.5)-(5.5-6.5) 135 6 0.014
SECX-10-7-40-135 10/7 40 (8.5-9.5)-(5.5-6.5) 135 6 0.014

* 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 SpiderFX™ embolic protection device.  The SpiderFX embolic protection device has been demonstrated to be compatible with the Protege RX carotid stent system in bench and animal testing.

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%.

 

See product catalog for complete, detailed product information.