Emboshield NAV6 Embolic Protection System

Emboshield NAV6 Embolic Protection System - Image 2

Emboshield NAV6 Embolic Protection System

Emboshield NAV6 Embolic

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.

EMBOLIC PROTECTION DEVICE FOR BOTH LOWER EXTREMITY AND CAROTID ARTERIES

Captures Effectively to Minimize 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 excellent 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 RX Acculink™ Carotid Stent System and the Xact™ Carotid Stent System.

* Data on file at Abbott.

References

Bioangiu et al. Comparative analysis of retrieved particulate debris after superficial femoral atherectomy using three different atherectomy methods. EuroIntervention, May 2012.
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.
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.
Philips Turbo-Elite, Medtronic TurboHawk PPES, and Boston Scientific Jetstream XC and SC. Test(s) performed by and data on file at Abbott.

IMPORTANT SAFETY INFORMATION

Emboshield NAV⁶ Embolic Protection System

Indications

The Emboshield NAV⁶ Embolic Protection System 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.

Contraindications

The Emboshield NAV 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.

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