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 WarningsNote: Safety information provided is for the United States. Refer to your region’s instructions for use for specific details.This therapy is not for everyone. Please consult your physician. A prescription is required. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.Brief statementIndicationsThe 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 both of following criteria:

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

Patients have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion

ContraindicationsUse 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.WarningOnly 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.Potential adverse eventsPotential adverse events which may be associated with the use of a stent in the common and/or external iliac arteries include, but are not limited to: abrupt closure, allergic reactions to procedural medications, contrast dye or device materials, amaurosis fugax, aneurysm, angina/coronary ischemia, arrhythmia, arterial occlusion or thrombosis at puncture site or remote site, arteriovenous fistula, bacteremia or septicemia, bleeding from anticoagulant or antiplatelet medications, bleeding with or without transfusion, cerebral edema, cerebral hemorrhage, cerebral ischemia or transient ischemic attack (TIA), congestive heart failure (CHF), death, detachment of a component of the device system, embolism (air, tissue, thrombus), emergent or urgent endarterectomy surgery (CEA), fever, filter thrombosis or occlusion, fluid overload, groin hematoma with or without surgical repair, hemorrhage with or without transfusion, hyperperfusion syndrome, hypotension or hypertension, infection and/or pain at the puncture site, ischemia or infarction of tissue/organ, myocardial infarction (MI), pain (head, neck), pseudoaneurysm, femoral, renal failure/insufficiency (new or worsening), restenosis of stented segment, seizure, severe unilateral headache, slow/no flow during procedure, stent/filter collapse or fracture, stent/filter entanglement or damage, stent/filter failure to deploy, stent embolization, migration or misplacement, stent or vessel thrombosis/occlusion, stroke/cerebrovascular accident (CVA), total occlusion of carotid artery, vessel dissection, flap, perforation or rupture, vessel spasm or recoil.See the instructions for use provided with the product for a complete list of warnings, precaution, adverse events, and device information.CautionFederal law (United States) restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.FTSOP113326-39bUC201712590aEN

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%.