Peripheral and biliary stents

Protégé™ RX self-expanding carotid stent system

<p>The Protégé™ RX self-expanding carotid stent system is available with straight or tapered models.</p>

Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).Please note that the intended use of a product may vary depending on geographical approvals.See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.If a device is eligible for eIFU usage, instructions for use can be found at the Medtronic website manuals.medtronic.com.Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.Medtronic products placed on European markets comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.Medtronic medical devices marketed in Spain are in compliance with the Spanish legislation in force.

Indications

The stent is indicated for treatment of stenoses of the common carotid artery (CCA), internal carotid artery (ICA), and carotid bifurcation. All indications related to the Protégé™ RX Self-expanding Carotid Stent are not approved globally, please refer to the complete Instructions for Use manual for the indication for Use approved in your geography.

Features

Predictable deployment

Proprietary EX.P.R.T.™ release technology essentially eliminates premature deployment or jumping
Minimal stent shortening
Unique anatomically designed tapered stent for better fit in the carotid bifurcation
Offers 0.014" rapid exchange catheter with 6 Fr 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.
The straight and tapered options offer customized fit in carotid vessels.

Manuals and Technical Guides

Find this technical manual in the product labeling supplied with each device.

The Protégé™ RX self-expanding carotid stent system is used in the treatment of patients at high risk for adverse events from carotid endarterectomy.

Ordering information

Straight

Item number	Uncon- strained stent diameter (mm)	Uncon- strained stent length (mm)	Recom- mended lumen size (mm)	Usable catheter length (cm)	Sheath size (Fr)	Guidewire acceptance (in)
SEPX-6-20-135	6	20	4.5-5.5	135	6	0.014
SEPX-6-30-135	6	30	4.5-5.5	135	6	0.014
SEPX-6-40-135	6	40	4.5-5.5	135	6	0.014
SEPX-6-60-135	6	60	4.5-5.5	135	6	0.014
SEPX-7-20-135	7	20	5.5-6.5	135	6	0.014
SEPX-7-30-135	7	30	5.5-6.5	135	6	0.014
SEPX-7-40-135	7	40	5.5-6.5	135	6	0.014
SEPX-7-60-135	7	60	5.5-6.5	135	6	0.014
SEPX-8-20-135	8	20	6.5-7.5	135	6	0.014
SEPX-8-30-135	8	30	6.5-7.5	135	6	0.014
SEPX-8-40-135	8	40	6.5-7.5	135	6	0.014
SEPX-8-60-135	8	60	6.5-7.5	135	6	0.014
SEPX-9-20-135	9	20	7.5-8.5	135	6	0.014
SEPX-9-30-135	9	30	7.5-8.5	135	6	0.014
SEPX-9-40-135	9	40	7.5-8.5	135	6	0.014
SEPX-9-60-135	9	60	7.5-8.5	135	6	0.014
SEPX-10-20-135	10	20	8.5-9.5	135	6	0.014
SEPX-10-30-135	10	30	8.5-9.5	135	6	0.014
SEPX-10-40-135	10	40	8.5-9.5	135	6	0.014
SEPX-10-60-135	10	60	8.5-9.5	135	6	0.014

Tapered

Item number	Uncon- strained stent diameter (mm)	Uncon- strained stent length (mm)	Recommended lumen size (mm)	Usable catheter length (cm)	Sheath size (Fr)	Guidewire acceptance (in)
SEPX-8-6-30-135	8/6	30	(6.5-7.5)-(4.5-5.5)	135	6	0.014
SEPX-8-6-40-135	8/6	40	(6.5-7.5)-(4.5-5.5)	135	6	0.014
SEPX-10-7-30-135	10/7	30	(8.5-9.5)-(5.5-6.5)	135	6	0.014
SEPX-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%.