FILTER

• 120-µm PORE SIZE
• Effectively captures debris while also allowing blood flow
• HIGH-STRENGTH NYLON FILTER MATERIAL
• Is designed to enhance capture efficiency by maintaining wall apposition and protecting the vessel wall from direct contact with the nitinol frame
• NON-THROMBOGENIC HYDROPHILIC COATING
• Is designed to reduce platelet or protein adhesion

1. BAREWIRE™ TECHNOLOGY

Is a proprietary wire technology that enables guide wire-only access through the lesion and ensures stable filter position

2. PROXIMAL MARKER BAND

Includes proprietary radiopaque markers for smooth tracking through tortuous anatomy

3. NITINOL FRAME

Is designed for outstanding circumferential wall apposition—even on a bend—and collapses into a low-profile wrap down during filter retrieval

4. CENTERED WIRE DESIGN

Prevents filter bias against the vessel wall and allows effective capture in all vessel types

5. PLATINUM TUNGSTEN MARKERS

Are radiopaque markers to convey vessel apposition and deployment status

6. 1-MM PORE-FREE ZONE AT DISTAL TIP

Prevents extrusion of embolic material during blood flow

7. DISTAL MARKER BAND

Includes proprietary radiopaque markers for smooth tracking through tortuous anatomy

8. BAREWIRE™ 0.019” STEP

Acts as a distal stop for the Filtration Element

DELIVERY WIRES FOR FLEXIBILITY AND SUPPORT

There are three types of BareWire™ delivery wires.

Distal Access: A soft BareWire™, it provides extra flexibility for successful access through torturous anatomy

Workhorse: Provides optimal flexibility and support for superb access through most anatomies

Support: Is designed to provide additional support for delivery of the filter in challenging arches

Filter Visibility

The deployment status and the vessel apposition can be visually confirmed because of the device’s radiopaque frame.

Fully Deployed

Fully Captured

Embolic Protection Devices can add a layer of protection during endovascular procedures in the lower extremities or carotids. In the lower extremities, downstream complications can be minimized and in the carotids, the stroke rate can be reduced with the use of EPDs1.

EXCELLENT OUTCOMES: EMBOSHIELD NAV6™ EPS CLINICAL DATA

Clinical Findings in Brief

Three trials evaluated carotid stenting with the Emboshield NAV6™ EPS and/or previous generation Abbott products.

• ACT I: Asymptomatic Carotid Trial I
• CHOICE: Carotid Stenting for High Surgical-Risk Patients; Evaluating Outcomes Through the CollectIon of Clinical Evidence
• Protect: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (CEA)

Summary of Clinical Trial Data for Emboshield NAV6™ Embolic Protection System

DS = Death or stroke DSMI = Death, stroke, or myocardial infarction CEA = Carotid endarterectomy

ACT I Trial2,5

The primary aim of this prospective, multicenter trial was to compare the outcomes of stenting with embolic protection vs carotid endarterectomy.

Patients

The 1,453 patients were randomly assigned to the stenting group (n = 1,089) or the CEA group (n = 364), all of whom met the following criteria:

• Asymptomatic, severe (> 70%) carotid stenosis
• ≤ 79 years of age
• Standard risk for CEA surgical complications

Findings

ACT I TRIAL CAROTID ARTERY STENTING (CAS)CAROTID ENDARTERECTOMYPrimary composite endpoint: DSMI (at 30 days) and ipsilateral stroke (31 days - 1 year)3.8%3.4%Freedom from ipsilateral stroke (31 days - 5 years)97.8%97.3%Freedom from clinically driven revascularization (5 years, p = 0.05)98.4%96.7%5 year survival87.1%89.4%

The authors concluded that:

• There were no significant differences in long-term (5-year) rates of stroke and survival between the two groups in this large randomized trial.
• CAS was found to be noninferior to CEA for the primary composite end point: DSMI within 30 days; or ipsilateral stroke within 1 year post procedure.

CHOICE Trial3

With 17,925 patients evaluated, the CHOICE trial represents the largest prospective, single-arm, adjudicated, multicenter CAS data set to date. The CHOICE study also provided additional post-market surveillance of RX Acculink™ Carotid Stent System and Abbott’s embolic protection systems.

Patients

Patient criteria included:

• Severe stenosis of ≥ 50% for symptomatic patients and ≥ 80% for asymptomatic patients
• High surgical risk for CEA

There were other notable aspects of the patient population:

• 22.6% who were age ≥ 80
• 24.4% who had heavy calcification at the target site

Findings

The 30-day findings included:

CHOICE TRIAL ALL PATIENTS

(N = 17,925)PATIENTS AGE < 80

(N = 13,868)DSMI4.2%3.4%DS3.8%3.0%Death or major stroke1.4%1.1%

The investigators concluded that CAS is a viable option for patients at high risk for CEA. In addition, favorable outcomes were observed in patients < 80 years of age.

PROTECT Trial4

Investigators undertook the PROTECT trial (n = 220) in an effort to evaluate the outcomes with improved device technology.

Patients

The PROTECT trial included only patients at high surgical risk for CEA, and severe stenosis:

• ≥ 50% for symptomatic patients
• ≥ 80% for asymptomatic patients

Findings

PROTECT TRIALDS (30 days)1.8%DSMI (30 days)2.3%Death or Major Stroke (30 days)0.5%Freedom from Ipsilateral Stroke (31 days – 3 years)98.8%

These data reveal improved outcomes compared to earlier high-risk CAS trials.

PROTECT Trial: Lower DSMI Rate Outcomes vs Other High Risk Carotid IDE Trials

NOTE: Results from clinical trials are not directly comparable. Information provided for educational purposes only.

Contraindications

The Emboshield NAV6™ Embolic Protection System is contraindicated for use in

• Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, Embolic Protection System.
• Patients with a known allergy or hypersensitivity to device materials (Nitinol, Nickel, Titanium) or contrast medium, who cannot be adequately premedicated.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.
• Inability to cross the lesion with the BareWire™ Filter Delivery Wire.
• Diffusely diseased vessels where there is no disease-free section in which to deploy the Filtration Element
• Insufficient straight section of vessel distal to the lesion to permit Filtration Element deployment.

Warnings

Use of the device should be restricted to physicians trained to the specifics of the device and to the Instructions for Use. Operators must be knowledgeable of the current medical literature and familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid and lower extremity interventional procedures.

Precautions

Precautions to prevent or reduce clotting should be taken when any interventional device is used. Flush or rinse all devices entering the vascular system with heparinized normal saline or alternative anticoagulant, prior to use.

The Emboshield NAV6™ Embolic Protection System must be used with a guiding catheter or introducer sheath to maintain adequate support for the BareWire™ Filter Delivery Wire throughout the procedure.

Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either pharmaceutical intervention or place of a temporary pacemaker, if needed.

Removal of the BareWire™ Filter Delivery Wire with the Emboshield NAV6™ Filtration Element through any interventional devices other than the Emboshield NAV6™ RX Retrieval Catheter has not been tested.

The minimum expanded stent internal diameter required for retrieval of a large embolic load is 2.5 mm.

As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems:

• Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, stent material (Nitinol, Nickel, Titanium) and drug reactions to anticoagulation, or antiplatelet drugs
• Vascular access complications which may require transfusion or vessel repair, including:
• Bleeding (ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
• Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation/rupture, and laceration
• Embolism (air, tissue, plaque, thrombotic material or device)
• Thrombophlebitis
• Target artery complications which may require additional intervention, including:
• Total occlusion or abrupt closure
• Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation/rupture
• Embolism (air, tissue, plaque, thrombotic material or device)
• Stenosis or restenosis
• Artery, stent, or filter thrombosis / occlusion thrombosis
• Vessel spasm
• Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias)
• Cardiac ischemic conditions (including myocardial ischemia, myocardial infarction, and unstable or stable angina pectoris)
• Stroke/Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA)
• System organ failures:
• Cardio Pulmonary failure
• Renal failure / insufficiency
• Blood cell disorders including heparin induce thrombocytopenia and other coagulopathy
• Hypotension/hypertension
• Peripheral nerve injury
• Other ischemic conditions/infarct
• Infection - local and systemic (including postprocedural)
• Nausea and vomiting
• Chest pain
• Edema/Cerebral edema and fluid overload
• Fever
• Pain, including headache
• Hyperperfusion syndrome
• Other neurologic and systemic complications
• Cerebral hemorrhage
• Death