ROADSAVER™ Carotid Stent System
NANOPARASOL Embolic Protection System

ROADSAVER^™ Carotid Stent System

INDICATIONS FOR USE: The Roadsaver Carotid Stent System, when used in conjunction with the Nanoparasol Embolic Protection System (EPS), is indicated for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy and meet the criteria outlined below:

1. Patients who have either de novo atherosclerotic or post endarterectomy restenotic lesion(s) in the internal carotid arteries or at the carotid bifurcation with ≥50% stenosis if symptomatic or ≥80% stenosis if asymptomatic (both defined by angiography), AND
2. Patients having a vessel with reference diameters between 3.5 mm and 9.0 mm at the target lesion.

CONTRAINDICATIONS: The Roadsaver Carotid Stent System is contraindicated for use in:

• Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated
• Patients with known hypersensitivity to nickel-titanium
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system, or stent system
• Patients with uncorrected bleeding disorders
• Lesions in the ostium of the common carotid artery
• Carotid vessel with <25mm gap between the target location of the distal end of the stent and the proximal end of the distal protection device.

RX ONLY. Refer to the product labels and package insert for complete contraindications, warnings, precautions, potential complications, and instructions for use.

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NANOPARASOL Embolic Protection System

INDICATIONS FOR USE: The NANOPARASOL EPS is indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the filter placement should be between 3.0 and 6.5 mm. 

CONTRAINDICATIONS: The NANOPARASOL Embolic Protection System is contraindicated for use in:

• Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs is contraindicated
• Patients with known hypersensitivity to nickel-titanium
• Patients with severe vascular tortuosity or anatomy that would preclude the landing zone requirement or the safe introduction of a guide wire, guide catheter, introducer sheath, an embolic protection device, delivery catheter, or retrieval catheter
• Patients with uncorrected bleeding disorders
• Lesions in the ostium of the common carotid artery 

RX ONLY. Refer to the product labels and package insert for complete contraindications, warnings, precautions, potential complications, and instructions for use.

Manufacturer: MicroVention, Inc., 35 Enterprise, Aliso Viejo, CA 92656, USA

Distributed by Terumo Medical Corporation, 265 Davidson Ave, Somerset, NJ 08873, USA