Emboshield NAV6 Embolic Protection System

CAPTURE WITH CONFIDENCE

Indicated for Carotids and Lower Extremities

The Emboshield NAV6™ Embolic Protection System, which includes BareWire™ Filter Delivery Wires, allows the guide wire to rotate and advance freely, independent of the Emboshield NAV6™ filter.*

The Emboshield NAV6™ EPS is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.¹

Embolic Protection Device for both Lower Extremity and Carotid Arteries

Captures Effectively to Minimise Downstream Complications^1-3

Centered wire design prevents bias against the vessel wall for effective debris capture.*
Circumferential nitinol frame maintains optimal wall apposition, even on a bend.*
Platinum-tungsten frame coils provide optimal visibility.*
Two sizes allow for easy selection and minimal lab inventory.

Limits Filter Movement and Maintains Wire Access Through Innovative BareWire™ Design*

The unique BareWire™ technology allows the wire to rotate and advance freely, independently of the filter.
The filter is designed to stay in place during device delivery.*
Continued wire access, after filter is fully retracted, allows for easy delivery of additional therapy.*

Navigates Skillfully Through Carotid and Lower Extremity Vasculature*

Various types of BareWires™—distal access, workhorse, and support—are designed for various carotid anatomies.
They promote navigational success through torturous anatomy and challenging arches.

Is Compatible with Various Atherectomy Options⁴

Emboshield NAV6™ EPS and BareWire™ are compatible with a variety of atherectomy types.
BareWire™ is available in 190 cm and 315 cm lengths.

In carotid procedures, the Emboshield NAV6™ EPS is used during stenting with the Xact™ Carotid Stent System.

* Data on file at Abbott.

1. Bioangiu et al. Comparative analysis of retrieved particulate debris after superficial femoral atherectomy using three different atherectomy methods. EuroIntervention, May 2012.

2. Bioangiu et al. Analysis of Retrieved Particulate Debris after Superficial Femoral Artery (SFA) Atherectomy Using the Pathway Jetstream G3 device. CCI, May 2011, 77(2) p. S57.

3. Mendes et al. Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices. JVS, February 2014, 59(2), 359-367.

4. Philips Turbo-Elite, Medtronic TurboHawk PPES, and Boston Scientific Jetstream XC and SC. Data on file at Abbott.

Unique Features: Filter and Barewire™ Delivery Wires

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

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. RADIOPAQUE MARKERS

To convey vessel apposition and deployment status

6. 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 easy 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

Data on file at Abbott

System Utilisation: Preparation, Delivery and Retrieval

Straightforward Preparation

The streamlined Emboshield NAV6™ EPS prep procedure requires three steps. Refer to the Instructions for Use for additional information.

1. Flush in Two Places

At the exit port of the delivery catheter

In the filter, to remove air bubbles

2. Pull the Filter into the Delivery Catheter

Pull until the filter is completely inside the delivery catheter, at which point the gold marker is adjacent to the delivery catheter tip

3. Check the Gold Marker

Visually check to ensure that the filter is fully loaded into the delivery catheter.

Instructional Videos

Streamlined 3-step preparation

Exchange of the BareWire™ from standard 190 cm to longer 315 cm (no audio)

Device deployment

Device retrieval

Optimal Outcomes: Emboshield NAV6™ EPS Clinical Data

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 minimised and in the carotids, the stroke rate can be reduced with the use of EPDs.¹

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

Banerjee A, Sarode K, Mohammad A, et al. Safety and Effectiveness of the Nav-6 Filter in Preventing Distal Embolization During Jetstream Atherectomy of Infrainguinal Peripheral Artery Lesions. J Invasive Cardiol. 2016;28(8):330-333. Kastrup, et al. Early Outcome of Carotid Angioplasty and Stenting With and Without Cerebral Protection Devices: A Systematic Review of the Literature. Stroke, Mar 2003, 34(3):813-9. Mendes et al. Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices. JVS, February 2014, 59(2), 359-367.
Rosenfield K, Matsumura JS, Chaturvedi S, et al. Randomized trial of stent versus surgery for asymptomatic carotid stenosis. N Engl J Med. 2016;374(11):1011-1120.
Metzger DC. The CHOICE prospective trial: carotid stenting in a post-market setting. VIVA 2013.
Matsumura JS, Gray W, Chaturvedi S, et al. Results of carotid artery stenting with distal embolic protection with improved systems: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) trial. J Vasc Surg. 2012; 55(4):968-976.e5.

Ordering Information

*BareWires™ are sold in packs of five

Abbott’s Peripheral Intervention Portfolio

CAROTID STENT SYSTEM >

EMBOLIC PROTECTION SYSTEM >

PERIPHERAL DILATATION CATHETERS >

PERIPHERAL GUIDE WIRES >

PERIPHERAL STENT SYSTEMS >

VASCULAR PLUGS >

VESSEL CLOSURE >

ENDOVASCULAR LEARNING LAB >

References

Emboshield NAV6™ – Instructions for Use (IFU)

MAT-2117129 v1.0

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Emboshield NAV6™ Embolic Protection System